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| ID | Type | Description | Link |
|---|---|---|---|
| P30AI054999 | U.S. NIH Grant/Contract | View source |
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This study was terminated after 6 patients due to loss of funding
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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This pilot study will evaluate the effects of the anti-diabetic drug Bydureon (exenatide extended-release formulation) on blood sugar levels and serum markers of inflammation in a cohort of 12 HIV-infected adults on combination antiretroviral therapy (cART) with untreated diabetes mellitus. Previous studies have shown that high levels of persistent systemic inflammation predict the development of cardiovascular and metabolic diseases in HIV-infected persons on cART (a group at very high risk of atherosclerosis and myocardial infarction). Bydureon has demonstrated potent anti-inflammatory effects in prior studies of non-HIV infected persons, which suggests that this agent may represent a unique and preferred medication for the treatment of insulin resistance in HIV-infected adults. The Investigators hypothesize that short-term (16 weeks) therapy with Bydureon will improve glucose tolerance and significantly reduce circulating plasma levels of interleukin-6 (IL-6) and highly-sensitive C-reactive protein (hsCRP), two biomarkers strongly implicated in the development of cardiovascular and metabolic diseases in diabetic, HIV-infected, cART-treated adults.
No further information. This was a single-arm trial to add an additional anti-diabetic medication to patients already known to be diabetic. The primary endpoint assessed whether the intervention reduced inflammation. There was no control arm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bydureon treatment | Experimental | Treatment for 16 weeks with extended-release Exenatide (Bydureon) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| extended-release exenatide | Drug | Single arm study - 2mg Bydureon every 7 days x 16 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum Highly-sensitive C-reactive Protein (hsCRP) Levels at Baseline and 16 Weeks | The primary outcome will be the change in hsCRP levels from baseline (pre-treatment) to 16 weeks of Bydureon treatment. | baseline and 16 weeks |
| Serum Interleukin 6 (IL-6) at Levels at Baseline and 16 Weeks | The primary outcome will be the change in serum IL-6 levels from baseline (pre-treatment) to 16 weeks of Bydureon treatment. | baseline and 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Soluble Tumor Necrosis Factor Alpha (TNF-α) Levels at Baseline and 16 Weeks | baseline and 16 weeks | |
| Serum Macrophage Chemotactic Protein-1 (MCP-1) Levels at Baseline and 16 Weeks | baseline and 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Peripheral Endothelial Tonography, as Measured by the Non-invasive EndoPAT System Using the LnRHI (Natural Log of Reactive Hyperemia Index), at Baseline and 16 Weeks | Normal: LnRHI > 0.51 Abnormal: LnRHI ≤ 0.51 | baseline and 16 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Koethe, MD | Vanderbilt University School of Medicine | Principal Investigator |
| C. William Wester, MD | Vanderbilt University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University | Nashville | Tennessee | 37240 | United States |
Individual participant data is protected by HIPPA and Vanderbilt University research regulations. Summary de-identified data is available if requested
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No consented participants were excluded prior to group assignment
Six HIV-infected participants recruited from the Vanderbilt Comprehensive Care Clinic between April 17, 2013 and May 6, 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bydureon Treatment | Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bydureon Treatment | Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Serum Highly-sensitive C-reactive Protein (hsCRP) Levels at Baseline and 16 Weeks | The primary outcome will be the change in hsCRP levels from baseline (pre-treatment) to 16 weeks of Bydureon treatment. | Change in hsCRP over 16 weeks of treatment | Posted | Median | Inter-Quartile Range | mg/dl | baseline and 16 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 | Bydureon Treatment | Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue and weakness | General disorders | Systematic Assessment | Self-reported |
Trial terminated after only 6 individuals enrolled due to lack of interest in participation from patients and expiration of funding. Results are not considered reliable due to low number of observations
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Koethe MD | Vanderbilt University Medical Center | 615-343-0533 | john.r.koethe@vanderbilt.edu |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000077270 | Exenatide |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014688 | Venoms |
| D045424 | Complex Mixtures |
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| Serum Macrophage Inflammatory Protein 1 Alpha (MIP-1 Alpha) Levels at Baseline and 16 Weeks | baseline and 16 weeks |
| Oral Glucose Insulin Sensitivity (OGIS) at Baseline and 16 Weeks | The Oral Glucose Insulin Sensitivity (OGIS) is a method for the assessment of insulin sensitivity from the oral glucose tolerance test. OGIS provides an index which is analogous to the index of insulin sensitivity obtained from the glucose clamp. OGIS values for glucose clearance are reported in units of ml/min per square meter of body surface area. Lower values indicate slower glucose clearance and higher insulin resistance. | baseline and 16 weeks |
| Serum Adipokine Leptin Levels at Baseline and 16 Weeks | baseline and 16 weeks |
| Body Mass Index at Baseline and 16 Weeks | 16 weeks |
| Serum TNF-a Receptor 1 Levels at Baseline and 16 Weeks | baseline and 16 weeks |
| Serum Soluble CD14 Levels at Baseline and 16 Weeks | baseline and 16 weeks |
| Serum TNF-a Receptor 2 Levels at Baseline and 16 Weeks | baseline and 16 weeks |
| Serum Hemoglobin A1c (HbA1c) Levels at Baseline and 16 Weeks | baseline and 16 weeks |
| Serum Triglycerides Levels at Baseline and 16 Weeks | baseline and 16 weeks |
| Serum Total Cholesterol Levels at Baseline and 16 Weeks | baseline and 16 weeks |
| Serum HDL Cholesterol Levels at Baseline and 16 Weeks | baseline and 16 weeks |
| Serum LDL Cholesterol Levels at Baseline and 16 Weeks | baseline and 16 weeks |
| Body Weight at Baseline and 16 Weeks | baseline and 16 weeks |
| Waist Circumference at Baseline and 16 Weeks | baseline and 16 weeks |
| Hip Circumference at Baseline and 16 Weeks | baseline and 16 weeks |
| Waist to Hip Ratio at Baseline and 16 Weeks | baseline and 16 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Serum Interleukin 6 (IL-6) at Levels at Baseline and 16 Weeks | The primary outcome will be the change in serum IL-6 levels from baseline (pre-treatment) to 16 weeks of Bydureon treatment. | Posted | Median | Inter-Quartile Range | mg/dl | baseline and 16 weeks |
|
|
|
|
| Secondary | Serum Soluble Tumor Necrosis Factor Alpha (TNF-α) Levels at Baseline and 16 Weeks | Posted | Mean | Inter-Quartile Range | pg/ml | baseline and 16 weeks |
|
|
|
|
| Secondary | Serum Macrophage Chemotactic Protein-1 (MCP-1) Levels at Baseline and 16 Weeks | Posted | Mean | Inter-Quartile Range | pg/ml | baseline and 16 weeks |
|
|
|
|
| Secondary | Serum Macrophage Inflammatory Protein 1 Alpha (MIP-1 Alpha) Levels at Baseline and 16 Weeks | Posted | Mean | Inter-Quartile Range | pg/ml | baseline and 16 weeks |
|
|
|
|
| Secondary | Oral Glucose Insulin Sensitivity (OGIS) at Baseline and 16 Weeks | The Oral Glucose Insulin Sensitivity (OGIS) is a method for the assessment of insulin sensitivity from the oral glucose tolerance test. OGIS provides an index which is analogous to the index of insulin sensitivity obtained from the glucose clamp. OGIS values for glucose clearance are reported in units of ml/min per square meter of body surface area. Lower values indicate slower glucose clearance and higher insulin resistance. | Posted | Mean | Inter-Quartile Range | ml/min/m^2 BSA | baseline and 16 weeks |
|
|
|
|
| Secondary | Serum Adipokine Leptin Levels at Baseline and 16 Weeks | Posted | Mean | Inter-Quartile Range | ng/ml | baseline and 16 weeks |
|
|
|
|
| Secondary | Body Mass Index at Baseline and 16 Weeks | Posted | Mean | Inter-Quartile Range | kg/m2 | 16 weeks |
|
|
|
|
| Secondary | Serum TNF-a Receptor 1 Levels at Baseline and 16 Weeks | Posted | Mean | Inter-Quartile Range | pg/ml | baseline and 16 weeks |
|
|
|
|
| Secondary | Serum Soluble CD14 Levels at Baseline and 16 Weeks | Posted | Mean | Inter-Quartile Range | pg/ml | baseline and 16 weeks |
|
|
|
|
| Secondary | Serum TNF-a Receptor 2 Levels at Baseline and 16 Weeks | Posted | Mean | Inter-Quartile Range | pg/ml | baseline and 16 weeks |
|
|
|
|
| Secondary | Serum Hemoglobin A1c (HbA1c) Levels at Baseline and 16 Weeks | Posted | Mean | Inter-Quartile Range | percentage of glycated haemoglobin | baseline and 16 weeks |
|
|
|
|
| Secondary | Serum Triglycerides Levels at Baseline and 16 Weeks | Posted | Mean | Inter-Quartile Range | mg/dL | baseline and 16 weeks |
|
|
|
|
| Secondary | Serum Total Cholesterol Levels at Baseline and 16 Weeks | Posted | Mean | Inter-Quartile Range | mg/dL | baseline and 16 weeks |
|
|
|
|
| Secondary | Serum HDL Cholesterol Levels at Baseline and 16 Weeks | Posted | Mean | Inter-Quartile Range | mg/dL | baseline and 16 weeks |
|
|
|
|
| Secondary | Serum LDL Cholesterol Levels at Baseline and 16 Weeks | Posted | Mean | Inter-Quartile Range | mg/dL | baseline and 16 weeks |
|
|
|
|
| Other Pre-specified | Peripheral Endothelial Tonography, as Measured by the Non-invasive EndoPAT System Using the LnRHI (Natural Log of Reactive Hyperemia Index), at Baseline and 16 Weeks | Normal: LnRHI > 0.51 Abnormal: LnRHI ≤ 0.51 | Posted | Mean | Inter-Quartile Range | units on a scale | baseline and 16 weeks |
|
|
|
|
| Secondary | Body Weight at Baseline and 16 Weeks | Posted | Mean | Inter-Quartile Range | kilograms | baseline and 16 weeks |
|
|
|
|
| Secondary | Waist Circumference at Baseline and 16 Weeks | Posted | Mean | Inter-Quartile Range | centimeters | baseline and 16 weeks |
|
|
|
|
| Secondary | Hip Circumference at Baseline and 16 Weeks | Posted | Mean | Inter-Quartile Range | centimeters | baseline and 16 weeks |
|
|
|
|
| Secondary | Waist to Hip Ratio at Baseline and 16 Weeks | Posted | Mean | Inter-Quartile Range | ratio | baseline and 16 weeks |
|
|
|
|
| 0 |
| 6 |
| 2 |
| 6 |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D014118 |
| Toxins, Biological |
| D001685 | Biological Factors |