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| ID | Type | Description | Link |
|---|---|---|---|
| R21DK122234 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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This project investigates the anti-obesity mechanisms of glucagon-like peptide-1 (GLP-1) analogs, which are used in the treatment of human obesity and diabetes mellitus. The investigators will test if GLP-1 induces secretion of interleukin-6 (IL-6), a cytokine that may collaborate with GLP-1 analogs to induce the formation of brown fat, which has anti-diabetic properties. The results will guide future obesity and diabetes mellitus therapies.
Incretins, the analogs of glucagon-like peptide-1 (GLP-1), improve glucose control in type 2 diabetes mellitus and counteract obesity through mechanisms that are not completely understood. The investigators' preliminary data show that, in prediabetic human subjects and mice, GLP-1 analog therapy induces an increase in plasma interleukin-6 (IL-6), a cytokine activating signal transducer and activator of transcription 3 (STAT3) signaling, which induces brown (beige) adipocyte differentiation in adipose tissue (AT). The investigators discovered that plasma IL-6 induction occurs through GLP-1 receptor (GLP-1R) stimulation in leukocytes. Interestingly, studies in rodents indicate that GLP-1 / GLP-1R signaling also induces AT beiging. Based on these observations, the investigators hypothesize that incretins induce AT browning in part via transient IL-6 / IL-6 receptor (IL-6R) / STAT3 signaling. The primary objective is to further elucidate the role of IL-6 and GLP-1 signaling in mediating beneficial metabolic effects of incretin therapy. Studies will be paralleled in a human clinical trial, a human cell culture model, and a mouse diet-induced obesity model. GLP-1 analog therapy combined with an IL-6 blocking antibody will be used. Specific Aim 1 is to (A) investigate IL-6 induction / downstream STAT3 signaling and AT browning upon incretin therapy in prediabetic human subjects; and (B) validate mice as a model to study incretin-induced IL-6 signaling as a mediator of AT browning. Specific Aim 2 is to (A) investigate if GLP-1 analog effects on beige adipogenesis depend on IL-6 signaling in human adipocyte progenitors; and (B) investigate if GLP-1 analog effects on beige adipogenesis depend on IL-6 signaling in mice. It is expected that 1) GLP-1 analog signaling via GLP-1R induces IL-6 secretion by leukocytes, and 2) GLP-1 analog therapy induces adipose tissue browning via both direct GLP-1 / GLP-1R signaling and indirect incretin-induced IL-6 / IL-6R / STAT3 signaling. The results of this novel study will give critical insights on the anti-obesity mechanisms of GLP-1 analogs and serve as the basis for developing more targeted therapies for diabetes and obesity. Understanding the anti-diabetic IL-6 effects will also be important for interpreting the results of IL-6 blockade, a therapeutic approach for patients with diabetes and other inflammatory conditions, which may need to be re-considered.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cyanocobalamin, then Dulaglutide | Experimental | Participants first received Cyanocobalamin (vitamin B12) 1000 mcg subcutaneous weekly for 6 weeks. After a washout period of 3 weeks, they then received Dulaglutide 0.75 mg subcutaneous weekly for 2 weeks, followed by 1.5 mg subcutaneous weekly for 4 weeks |
|
| Dulaglutide, then Cyanocobalamin | Experimental | Participants first received Dulaglutide 0.75 mg subcutaneous weekly for 2 weeks, followed by 1.5 mg subcutaneous weekly for 4 weeks. After a washout period of of 3 weeks, they then Cyanocobalamin (vitamin B12) 1000 mcg subcutaneous weekly for 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyanocobalamin | Drug | Cyanocobalamin (vitamin B12) 1000 mcg subcutaneous weekly for 6 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cytokine Interleukin-6 (IL-6) Messenger Ribonucleic Acid (mRNA) Level (From Adipose Tissue) | natural log transformed data is reported | 6 weeks after start of each intervention |
| Uncoupling Protein 1 (UCP1) Messenger Ribonucleic Acid (mRNA) Level (From Adipose Tissue) | Uncoupling protein 1 (UCP1) is a marker of beige/brown fat. natural log transformed data is reported | 6 weeks after start of each intervention |
| Signal Transducer and Activator of Transcription 3 (STAT3) Band Intensity/Western Blot (From Adipose Tissue) | signaling intermediary with interleukin-6 | 6 weeks after start of each intervention |
| Measure | Description | Time Frame |
|---|---|---|
| PR Domain Containing 16 (PRDM16) Messenger Ribonucleic Acid (mRNA) Level ((From Adipose Tissue) | PR domain containing 16 (PRDM16) is a marker of beige/brown fat. natural log transformed data is reported. | 6 weeks after start of each intervention |
| Nicotinamide Adenine Dinucleotide Dehydrogenase (Ubiquinone) Iron-sulfur protein3 (NDUFS3) (From Adipose Tissue) |
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Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Absalon D Gutierrez, MD | The University of Texas Health Science Center at Houston, Dept. of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
We will share all participant data (which will be deidentified) regarding our plasma samples, subcutaneous adipose tissue samples, and peripheral blood mononuclear cells. A study protocol and statistical analysis plan will be available as specified per policy of clinicaltrials.gov.
Data will become available one year after the primary completion date of the clinical trial, or 6 months post-publication, or 18 months after award end date - whichever comes first. Data will then be available indefinitely.
Anyone can access the data via clinicaltrials.gov. If applicable, data will also be shared via the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Information Network.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cyanocobalamin, Then Dulaglutide | Participants first received Cyanocobalamin (vitamin B12) 1000 mcg subcutaneous weekly for 6 weeks. After a washout period of 3 weeks, they then received Dulaglutide 0.75 mg subcutaneous weekly for 2 weeks, followed by 1.5 mg subcutaneous weekly for 4 weeks Cyanocobalamin: Cyanocobalamin (vitamin B12) 1000 mcg subcutaneous weekly for 6 weeks. Dulaglutide: Dulaglutide 0.75 mg subcutaneous weekly for 2 weeks, followed by 1.5 mg subcutaneous weekly for 4 weeks |
| FG001 | Dulaglutide, Then Cyanocobalamin | Participants first received Dulaglutide 0.75 mg subcutaneous weekly for 2 weeks, followed by 1.5 mg subcutaneous weekly for 4 weeks. After a washout period of of 3 weeks, they then Cyanocobalamin (vitamin B12) 1000 mcg subcutaneous weekly for 6 weeks. Cyanocobalamin: Cyanocobalamin (vitamin B12) 1000 mcg subcutaneous weekly for 6 weeks. Dulaglutide: Dulaglutide 0.75 mg subcutaneous weekly for 2 weeks, followed by 1.5 mg subcutaneous weekly for 4 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (6 Weeks) |
| ||||||||||||||||
| Washout (3 Weeks) |
| ||||||||||||||||
| Second Intervention (6 Weeks) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cyanocobalamin, Then Dulaglutide | Participants first received Cyanocobalamin (vitamin B12) 1000 mcg subcutaneous weekly for 6 weeks. After a washout period of 3 weeks, they then received Dulaglutide 0.75 mg subcutaneous weekly for 2 weeks, followed by 1.5 mg subcutaneous weekly for 4 weeks Cyanocobalamin: Cyanocobalamin (vitamin B12) 1000 mcg subcutaneous weekly for 6 weeks. Dulaglutide: Dulaglutide 0.75 mg subcutaneous weekly for 2 weeks, followed by 1.5 mg subcutaneous weekly for 4 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cytokine Interleukin-6 (IL-6) Messenger Ribonucleic Acid (mRNA) Level (From Adipose Tissue) | natural log transformed data is reported | Posted | Mean | 95% Confidence Interval | natural log(arbitrary units) | 6 weeks after start of each intervention |
|
17 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cyanocobalamin | Cyanocobalamin: Cyanocobalamin (vitamin B12) 1000 mcg subcutaneous weekly for 6 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| vasovagal response | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Absalon D Gutierrez, MD | The University of Texas Health Science Center at Houston | 713-500-6641 | absalon.d.gutierrez@uth.tmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 6, 2023 | Oct 3, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 6, 2023 | Oct 4, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| D050177 | Overweight |
| D009765 | Obesity |
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D014805 | Vitamin B 12 |
| C555680 | dulaglutide |
| ID | Term |
|---|---|
| D045728 | Corrinoids |
| D045725 | Tetrapyrroles |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 |
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Crossover clinical trial
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|
| Dulaglutide | Drug | Dulaglutide 0.75 mg subcutaneous weekly for 2 weeks, followed by 1.5 mg subcutaneous weekly for 4 weeks |
|
|
marker of beige/brown fat |
| 6 weeks after start of each intervention |
| Beta1-adrenoceptor (ADRB1) (From Adipose Tissue) | marker of beige/brown fat | 6 weeks after start of each intervention |
| Beta2-adrenoceptor (ADRB2) (From Adipose Tissue) | marker of beige/brown fat | 6 weeks after start of each intervention |
| Beta3-adrenoceptor (ADRB3) (From Adipose Tissue) | marker of beige/brown fat | 6 weeks after start of each intervention |
| Nuclear Factor Kappa B (NfKappaB) p65 Band Intensity/Western Blot (From Peripheral Blood Mononuclear Cells) | signaling intermediary with interleukin-6 | 6 weeks after start of each intervention |
| Interleukin-6 (IL-6) mRNA (From Peripheral Blood Mononuclear Cells) | cytokine | 6 weeks after start of each intervention |
| IL-6 (From Peripheral Blood Mononuclear Cells) | cytokine | 6 weeks after start of each intervention |
| Suppressor of Cytokine Signaling 3 (SOCS3) Band Intensity/Western Blot (From Peripheral Blood Mononuclear Cells) | signaling intermediary with interleukin-6 | 6 weeks after start of each intervention |
| Cytokine IL-6 Level (From Plasma) | natural log transformed data is reported. The "Measure Type" indicated as "Mean" actually refers to a "Adjusted Mean." Mean was adjusted for meteorological season. The meteorological season (i.e., spring, summer, fall, and winter) was adjusted for in the multivariable analysis as a potential confounding factor, since imbalances in ambient temperature between study arms could affect the findings. | 6 weeks after start of each intervention |
| Free Fatty Acids Level (From Plasma) | Free fatty acids level is a marker for insulin resistance. natural log transformed data is reported The "Measure Type" indicated as "Mean" actually refers to a "Adjusted Mean." Mean was adjusted for meteorological season. The meteorological season (i.e., spring, summer, fall, and winter) was adjusted for in the multivariable analysis as a potential confounding factor, since imbalances in ambient temperature between study arms could affect the findings. | 6 weeks after start of each intervention |
| Insulin Level (From Plasma) | Insulin Level is a marker of insulin resistance. natural log transformed data is reported. The "Measure Type" indicated as "Mean" actually refers to a "Adjusted Mean." Mean was adjusted for meteorological season. The meteorological season (i.e., spring, summer, fall, and winter) was adjusted for in the multivariable analysis as a potential confounding factor, since imbalances in ambient temperature between study arms could affect the findings. | 6 weeks after start of each intervention |
| Glucose Level (From Plasma) | Glucose Level is a marker of insulin resistance. The "Measure Type" indicated as "Mean" actually refers to a "Adjusted Mean." Mean was adjusted for meteorological season. The meteorological season (i.e., spring, summer, fall, and winter) was adjusted for in the multivariable analysis as a potential confounding factor, since imbalances in ambient temperature between study arms could affect the findings. | 6 weeks after start of each intervention |
| Tumor Necrosis Factor - Alpha (From Plasma) | natural log transformed data is reported. The "Measure Type" indicated as "Mean" actually refers to a "Adjusted Mean." Mean was adjusted for meteorological season. The meteorological season (i.e., spring, summer, fall, and winter) was adjusted for in the multivariable analysis as a potential confounding factor, since imbalances in ambient temperature between study arms could affect the findings. | 6 weeks after start of each intervention |
| Interleukin-4 (From Plasma) | cytokine | 6 weeks after start of each intervention |
| Interleukin-10 (From Plasma) | cytokine | 6 weeks after start of each intervention |
| Interleukin-11 (From Plasma) | cytokine | 6 weeks after start of each intervention |
| Interleukin-13 (From Plasma) | cytokine | 6 weeks after start of each intervention |
| Glucagon-like Peptide-1 (From Plasma) | The "Measure Type" indicated as "Mean" actually refers to a "Adjusted Mean." Mean was adjusted for meteorological season. The meteorological season (i.e., spring, summer, fall, and winter) was adjusted for in the multivariable analysis as a potential confounding factor, since imbalances in ambient temperature between study arms could affect the findings. | 6 weeks after start of each intervention |
| Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) | Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) is a marker of insulin resistance, calculated according to the formula: fasting insulin (mU/mL) x fasting glucose (mmol/L)/22.5 The "Measure Type" indicated as "Mean" actually refers to a "Adjusted Mean." Mean was adjusted for meteorological season. The meteorological season (i.e., spring, summer, fall, and winter) was adjusted for in the multivariable analysis as a potential confounding factor, since imbalances in ambient temperature between study arms could affect the findings. | 6 weeks after start of each intervention |
| Fat Browning Measured as Standard Uptake Value (From Positron Emission Tomography - Computed Tomography (PET-CT) Reading) | The "Measure Type" indicated as "Mean" actually refers to a "Adjusted Mean." Mean was adjusted for meteorological season. The meteorological season (i.e., spring, summer, fall, and winter) was adjusted for in the multivariable analysis as a potential confounding factor, since imbalances in ambient temperature between study arms could affect the findings. | 6 weeks after start of each intervention |
| Oroboros Oxygen Consumption | measure of oxygen consumption | 6 weeks after start of each intervention |
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| BG001 | Dulaglutide, Then Cyanocobalamin | Participants first received Dulaglutide 0.75 mg subcutaneous weekly for 2 weeks, followed by 1.5 mg subcutaneous weekly for 4 weeks. After a washout period of of 3 weeks, they then Cyanocobalamin (vitamin B12) 1000 mcg subcutaneous weekly for 6 weeks. Cyanocobalamin: Cyanocobalamin (vitamin B12) 1000 mcg subcutaneous weekly for 6 weeks. Dulaglutide: Dulaglutide 0.75 mg subcutaneous weekly for 2 weeks, followed by 1.5 mg subcutaneous weekly for 4 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Mean | Standard Deviation | kilograms per square meter |
|
| Systolic Blood Pressure | Mean | Standard Deviation | millimeters of mercury |
|
| Diastolic Blood Pressure | Mean | Standard Deviation | millimeters of mercury |
|
| Fasting Glucose Level | Mean | Standard Deviation | milligrams per deciliter |
|
| percentage of glycosylated hemoglobin | Mean | Standard Deviation | percentage of glycosylated hemoglobin" |
|
| Triglycerides Level | Mean | Standard Deviation | milligrams per deciliter |
|
| Total Cholesterol Level | Mean | Standard Deviation | milligrams per deciliter |
|
| high-density lipoprotein (HDL) Cholesterol Level | Mean | Standard Deviation | milligrams per deciliter |
|
| low-density lipoprotein (LDL) Cholesterol Level | Mean | Standard Deviation | milligrams per deciliter |
|
| aspartate aminotransferase (AST) Level | Mean | Standard Deviation | units per liter |
|
| alanine aminotransferase (ALT) Level | Mean | Standard Deviation | units per liter |
|
| Creatinine Level | Mean | Standard Deviation | milligrams per deciliter |
|
| Hemoglobin Level | Mean | Standard Deviation | grams per deciliter |
|
| Platelets Count | Mean | Standard Deviation | billion cells per liter |
|
| thyroid-stimulating hormone (TSH) level | Mean | Standard Deviation | milli-international units per liter |
|
| Vitamin B12 Level | Mean | Standard Deviation | picograms per milliliter |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | Uncoupling Protein 1 (UCP1) Messenger Ribonucleic Acid (mRNA) Level (From Adipose Tissue) | Uncoupling protein 1 (UCP1) is a marker of beige/brown fat. natural log transformed data is reported | Posted | Mean | 95% Confidence Interval | natural log(arbitrary units) | 6 weeks after start of each intervention |
|
|
|
| Primary | Signal Transducer and Activator of Transcription 3 (STAT3) Band Intensity/Western Blot (From Adipose Tissue) | signaling intermediary with interleukin-6 | Data were not collected for this outcome measure. | Posted | 6 weeks after start of each intervention |
|
|
| Secondary | PR Domain Containing 16 (PRDM16) Messenger Ribonucleic Acid (mRNA) Level ((From Adipose Tissue) | PR domain containing 16 (PRDM16) is a marker of beige/brown fat. natural log transformed data is reported. | Posted | Mean | 95% Confidence Interval | natural log(arbitrary units) | 6 weeks after start of each intervention |
|
|
|
| Secondary | Nicotinamide Adenine Dinucleotide Dehydrogenase (Ubiquinone) Iron-sulfur protein3 (NDUFS3) (From Adipose Tissue) | marker of beige/brown fat | Data were not collected for this outcome measure. | Posted | 6 weeks after start of each intervention |
|
|
| Secondary | Beta1-adrenoceptor (ADRB1) (From Adipose Tissue) | marker of beige/brown fat | Data were not collected for this outcome measure. | Posted | 6 weeks after start of each intervention |
|
|
| Secondary | Beta2-adrenoceptor (ADRB2) (From Adipose Tissue) | marker of beige/brown fat | Data were not collected for this outcome measure. | Posted | 6 weeks after start of each intervention |
|
|
| Secondary | Beta3-adrenoceptor (ADRB3) (From Adipose Tissue) | marker of beige/brown fat | Data were not collected for this outcome measure. | Posted | 6 weeks after start of each intervention |
|
|
| Secondary | Nuclear Factor Kappa B (NfKappaB) p65 Band Intensity/Western Blot (From Peripheral Blood Mononuclear Cells) | signaling intermediary with interleukin-6 | Data were not collected for this outcome measure. | Posted | 6 weeks after start of each intervention |
|
|
| Secondary | Interleukin-6 (IL-6) mRNA (From Peripheral Blood Mononuclear Cells) | cytokine | Data were not collected for this outcome measure. | Posted | 6 weeks after start of each intervention |
|
|
| Secondary | IL-6 (From Peripheral Blood Mononuclear Cells) | cytokine | Data were not collected for this outcome measure. | Posted | 6 weeks after start of each intervention |
|
|
| Secondary | Suppressor of Cytokine Signaling 3 (SOCS3) Band Intensity/Western Blot (From Peripheral Blood Mononuclear Cells) | signaling intermediary with interleukin-6 | Data were not collected for this outcome measure. | Posted | 6 weeks after start of each intervention |
|
|
| Secondary | Cytokine IL-6 Level (From Plasma) | natural log transformed data is reported. The "Measure Type" indicated as "Mean" actually refers to a "Adjusted Mean." Mean was adjusted for meteorological season. The meteorological season (i.e., spring, summer, fall, and winter) was adjusted for in the multivariable analysis as a potential confounding factor, since imbalances in ambient temperature between study arms could affect the findings. | Posted | Mean | 95% Confidence Interval | natural log(picograms per milliliter) | 6 weeks after start of each intervention |
|
|
|
| Secondary | Free Fatty Acids Level (From Plasma) | Free fatty acids level is a marker for insulin resistance. natural log transformed data is reported The "Measure Type" indicated as "Mean" actually refers to a "Adjusted Mean." Mean was adjusted for meteorological season. The meteorological season (i.e., spring, summer, fall, and winter) was adjusted for in the multivariable analysis as a potential confounding factor, since imbalances in ambient temperature between study arms could affect the findings. | Posted | Mean | 95% Confidence Interval | natural log(nanomoles per liter) | 6 weeks after start of each intervention |
|
|
|
| Secondary | Insulin Level (From Plasma) | Insulin Level is a marker of insulin resistance. natural log transformed data is reported. The "Measure Type" indicated as "Mean" actually refers to a "Adjusted Mean." Mean was adjusted for meteorological season. The meteorological season (i.e., spring, summer, fall, and winter) was adjusted for in the multivariable analysis as a potential confounding factor, since imbalances in ambient temperature between study arms could affect the findings. | Posted | Mean | 95% Confidence Interval | natural log(picomoles per liter) | 6 weeks after start of each intervention |
|
|
|
| Secondary | Glucose Level (From Plasma) | Glucose Level is a marker of insulin resistance. The "Measure Type" indicated as "Mean" actually refers to a "Adjusted Mean." Mean was adjusted for meteorological season. The meteorological season (i.e., spring, summer, fall, and winter) was adjusted for in the multivariable analysis as a potential confounding factor, since imbalances in ambient temperature between study arms could affect the findings. | Posted | Mean | 95% Confidence Interval | milligrams per deciliter | 6 weeks after start of each intervention |
|
|
|
| Secondary | Tumor Necrosis Factor - Alpha (From Plasma) | natural log transformed data is reported. The "Measure Type" indicated as "Mean" actually refers to a "Adjusted Mean." Mean was adjusted for meteorological season. The meteorological season (i.e., spring, summer, fall, and winter) was adjusted for in the multivariable analysis as a potential confounding factor, since imbalances in ambient temperature between study arms could affect the findings. | Posted | Mean | 95% Confidence Interval | natural log(picograms per milliliter) | 6 weeks after start of each intervention |
|
|
|
| Secondary | Interleukin-4 (From Plasma) | cytokine | Data were not collected for this outcome measure. | Posted | 6 weeks after start of each intervention |
|
|
| Secondary | Interleukin-10 (From Plasma) | cytokine | Data were not collected for this outcome measure. | Posted | 6 weeks after start of each intervention |
|
|
| Secondary | Interleukin-11 (From Plasma) | cytokine | Data were not collected for this outcome measure. | Posted | 6 weeks after start of each intervention |
|
|
| Secondary | Interleukin-13 (From Plasma) | cytokine | Data were not collected for this outcome measure. | Posted | 6 weeks after start of each intervention |
|
|
| Secondary | Glucagon-like Peptide-1 (From Plasma) | The "Measure Type" indicated as "Mean" actually refers to a "Adjusted Mean." Mean was adjusted for meteorological season. The meteorological season (i.e., spring, summer, fall, and winter) was adjusted for in the multivariable analysis as a potential confounding factor, since imbalances in ambient temperature between study arms could affect the findings. | Posted | Mean | 95% Confidence Interval | picomoles per milliliter | 6 weeks after start of each intervention |
|
|
|
| Secondary | Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) | Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) is a marker of insulin resistance, calculated according to the formula: fasting insulin (mU/mL) x fasting glucose (mmol/L)/22.5 The "Measure Type" indicated as "Mean" actually refers to a "Adjusted Mean." Mean was adjusted for meteorological season. The meteorological season (i.e., spring, summer, fall, and winter) was adjusted for in the multivariable analysis as a potential confounding factor, since imbalances in ambient temperature between study arms could affect the findings. | Posted | Mean | 95% Confidence Interval | HOMA-IR score | 6 weeks after start of each intervention |
|
|
|
| Secondary | Fat Browning Measured as Standard Uptake Value (From Positron Emission Tomography - Computed Tomography (PET-CT) Reading) | The "Measure Type" indicated as "Mean" actually refers to a "Adjusted Mean." Mean was adjusted for meteorological season. The meteorological season (i.e., spring, summer, fall, and winter) was adjusted for in the multivariable analysis as a potential confounding factor, since imbalances in ambient temperature between study arms could affect the findings. | Posted | Mean | 95% Confidence Interval | standard uptake value | 6 weeks after start of each intervention |
|
|
|
| Secondary | Oroboros Oxygen Consumption | measure of oxygen consumption | Data were not collected for this outcome measure. | Posted | 6 weeks after start of each intervention |
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 1 |
| 23 |
| EG001 | Dulaglutide | Dulaglutide: Dulaglutide 0.75 mg subcutaneous weekly for 2 weeks, followed by 1.5 mg subcutaneous weekly for 4 weeks | 0 | 23 | 0 | 23 | 0 | 23 |
Not provided
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| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |