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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23DK109284-01 | 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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To investigate whether longer-term improvement of glycemic control in poorly controlled diabetes patients with a 12-week intensified insulin treatment regimen will lead to decreased polyol pathway activity.
Polyol pathway activity will decrease in diabetic individuals who undergo intensification of their insulin treatment regimens as reflected by lower baseline brain intracellular fructose levels and higher intracellular glutathione levels. Furthermore, following longer-term improved glycemic control, patients may also have down-regulation of the pathway as reflected by decreased production of intracellular fructose in response to hyperglycemic clamp.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| type 2 diabetes mellitus | Active Comparator | Subjects with type 2 diabetes on insulin. |
|
| type 1 diabetes mellitus | Active Comparator | Subjects with type 1 diabetes on insulin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin | Drug | Insulin regimens will be adjusted on a weekly basis as needed to achieve a target blood glucose level. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c Levels | HbA1c levels measured by MRS scanning during a hyperglycaemic clamp. Result reported is the mean decrease in HbA1C. A decrease in HbA1c indicates improvement in brain glucose levels. | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Gluthathione | baseline MRS scan to measure gluthathione | 0 weeks |
| Gluthathione | MRS scan to measure gluthathione | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Optional Hyperglycemic Clamp | Hyperglycemic clamp administered to measure glucose levels. Data represented is the number of participants the clamp was used on successfully. | upon enrollment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janice Hwang, MD | Section of Endocrinology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Anylan Center | New Haven | Connecticut | 06511 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35247067 | Derived | Sanchez-Rangel E, Gunawan F, Jiang L, Savoye M, Dai F, Coppoli A, Rothman DL, Mason GF, Hwang JJ. Reversibility of brain glucose kinetics in type 2 diabetes mellitus. Diabetologia. 2022 May;65(5):895-905. doi: 10.1007/s00125-022-05664-y. Epub 2022 Mar 5. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Type 2 Diabetes Mellitus | Subjects with type 2 diabetes on insulin. Insulin: Insulin regimens will be adjusted on a weekly basis as needed to achieve a target blood glucose level. exercise: Exercise in accordance to the guidelines established by the American Diabetes Association. Dietary counseling: Dietary counseling in accordance to the guidelines established by the American Diabetes Association. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Type 2 Diabetes Mellitus | Subjects with type 2 diabetes on insulin. Insulin: Insulin regimens will be adjusted on a weekly basis as needed to achieve a target blood glucose level. exercise: Exercise in accordance to the guidelines established by the American Diabetes Association. Dietary counseling: Dietary counseling in accordance to the guidelines established by the American Diabetes Association. |
| 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 | Change in HbA1c Levels | HbA1c levels measured by MRS scanning during a hyperglycaemic clamp. Result reported is the mean decrease in HbA1C. A decrease in HbA1c indicates improvement in brain glucose levels. | Posted | Mean | Standard Deviation | mmol/mol | Baseline and 12 weeks |
|
|
Adverse event data were collected over the course of the study from baseline up to 24 months.
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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 | Type 2 Diabetes Mellitus | Subjects with type 2 diabetes on insulin. Insulin: Insulin regimens will be adjusted on a weekly basis as needed to achieve a target blood glucose level. exercise: Exercise in accordance to the guidelines established by the American Diabetes Association. Dietary counseling: Dietary counseling in accordance to the guidelines established by the American Diabetes Association. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Sanchez Rangel, MD | Yale School Of Medicine | 203-737-6067 | elizabeth.sanchezrangel@yale.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 | Jun 14, 2021 | Nov 3, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 14, 2021 | Feb 1, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D007328 | Insulin |
| D015444 | Exercise |
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| exercise | Behavioral | Exercise in accordance to the guidelines established by the American Diabetes Association. |
|
| Dietary counseling | Dietary Supplement | Dietary counseling in accordance to the guidelines established by the American Diabetes Association. |
|
| Plasma Glucose | MRS scan to measure plasma glucose | 0 weeks |
| Plasma Glucose | MRS scan to measure plasma glucose | 12 weeks |
| Plasma Fructose | MRS scan to measure plasma fructose | 0 weeks |
| Plasma Fructose | MRS scan to measure plasma fructose | 12 weeks |
| Plasma Insulin | MRS scan to measure plasma insulin | 0 weeks |
| Plasma Insulin | MRS scan to measure plasma insulin | 12 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Duration of Diabetes | Mean | Standard Deviation | years |
|
| BMI | Mean | Standard Deviation | kilograms/meter square |
|
| Weight | Mean | Standard Deviation | kilograms |
|
| HbA1c | Mean | Standard Deviation | mmol/mol |
|
| HbA1c | Mean | Standard Deviation | percentage glycated hemoglobin |
|
| Counts |
|---|
| Participants |
|
|
|
| Secondary | Gluthathione | baseline MRS scan to measure gluthathione | Data for this outcome not collected. | Posted | 0 weeks |
|
|
| Secondary | Gluthathione | MRS scan to measure gluthathione | Data for this outcome not collected. | Posted | 12 weeks |
|
|
| Secondary | Plasma Glucose | MRS scan to measure plasma glucose | Posted | Mean | Standard Deviation | mmol/l | 0 weeks |
|
|
|
| Secondary | Plasma Glucose | MRS scan to measure plasma glucose | Posted | Mean | Standard Deviation | mmol/l | 12 weeks |
|
|
|
|
| Secondary | Plasma Fructose | MRS scan to measure plasma fructose | Data for this outcome not collected. | Posted | 0 weeks |
|
|
| Secondary | Plasma Fructose | MRS scan to measure plasma fructose | Data for this outcome not collected. | Posted | 12 weeks |
|
|
| Secondary | Plasma Insulin | MRS scan to measure plasma insulin | Posted | Mean | Standard Deviation | μU/ml | 0 weeks |
|
|
|
|
| Secondary | Plasma Insulin | MRS scan to measure plasma insulin | Posted | Mean | Standard Deviation | μU/ml | 12 weeks |
|
|
|
|
| Other Pre-specified | Optional Hyperglycemic Clamp | Hyperglycemic clamp administered to measure glucose levels. Data represented is the number of participants the clamp was used on successfully. | Posted | Number | participants | upon enrollment |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
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| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |