Pilot Study of Bydureon to Treat Diabetes in HIV-infected Adults
This study is not yet open for participant recruitment.
Verified February 2013 by Vanderbilt University
Sponsor:
Vanderbilt University
Collaborator:
Information provided by (Responsible Party):
John R. Koethe, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01791465
First received: February 11, 2013
Last updated: February 13, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Human Immunodeficiency Virus Infection Diabetes Mellitus |
Drug: extended-release exenatide |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pilot Study of Extended-release Exenatide to Improve Glucose Control and Reduce Systemic Inflammation in Diabetic, HIV-infected Adults on Antiretroviral Therapy |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
Drug Information available for:
Exenatide
U.S. FDA Resources
Further study details as provided by Vanderbilt University:
Primary Outcome Measures:
- Change in serum interleukin 6 (IL-6) and highly-sensitive C-reactive protein (hsCRP) levels [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]The primary outcome will be the change in serum IL-6 and hsCRP levels from baseline (pre-treatment) to 16 weeks of Bydureon treatment.
Secondary Outcome Measures:
- Change from baseline to 16 weeks in serum levels of soluble tumor necrosis factor alpha (TNF-α) receptor 1 & 2, cystatin C, macrophage chemotactic protein-1 (MCP-1), macrophage inflammatory protein 1 alpha (MIP-1α), and interleukin 1 beta (IL-1β) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- The change from baseline to 16 weeks in the response to an oral glucose tolerance challenge and in serum hemoglobin A1c levels [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- The change from baseline to 16 weeks in serum LDL cholesterol, HDL cholesterol, total cholesterol, & triglycerides [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- The change from baseline to 16 weeks in serum adipokine (leptin and adiponectin) levels [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- The change from baseline to 16 weeks in body fat mass and distribution, anthropometrics, and body mass index [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Other Outcome Measures:
- The change from baseline to 16 weeks in peripheral endothelial tonography, as measured by the non-invasive EndoPAT system [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 12 |
| Study Start Date: | March 2013 |
| Estimated Study Completion Date: | August 2014 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Bydureon treatment
Treatment for 16 weeks with extended-release Exenatide (Bydureon)
|
Drug: extended-release exenatide
Other Name: Bydureon
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age ≥ 18 years
- Body mass index ≥ 25 kg/m2
- Glycosylated hemoglobin (A1C) value ≥ 6.5% OR having a fasting blood glucose ≥ 126 mg/dL
- On stable antiretroviral therapy for ≥ 12 months (with a fully suppressed plasma HIV-1 RNA level)
- Negative serum pregnancy test (females only)
Exclusion Criteria:
- History of pancreatitis
- Screening serum lipase value greater than or equal to 2 times the upper limit of normal (≥ 420 U/L)
- History of pancreatic cancer or thyroid cancer in patient, a first-degree relative, or a grandparent
- History of Multiple Endocrine Neoplasia (MEN) 2 syndrome
- History of gastroparesis, inflammatory bowel disease, and/or other severe gastrointestinal disease
- Estimated glomerular filtration rate (eGFR) ≤ 50 mls/minute
- Documented history of hypoglycemia (blood glucose <40 mg/dl)
- Active moderate-heavy alcohol use (more than 2 drinks/day) or >4 drinks in a single 24 hour period
- On an anti-diabetic medication within 3 months of enrollment
- On an HMG-CoA reductase inhibitor (statin) within 3 months of enrollment
- Persons on a didanosine (ddI) and/or stavudine (d4T)-containing cART (due to the heightened risk of pancreatitis)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01791465
Contacts
| Contact: Vicki Bailey | 615-936-7143 | vicki.bailey@vanderbilt.edu |
| Contact: John Koethe, MD | 615-322-2035 | john.r.koethe@vanderbilt.edu |
Locations
| United States, Tennessee | |
| Vanderbilt University | Not yet recruiting |
| Nashville, Tennessee, United States, 37240 | |
| Contact: Vick1 Bailey 615-936-7143 vicki.bailey@vanderbilt.edu | |
| Principal Investigator: John Koethe, MD | |
| Principal Investigator: C. William Wester, MD | |
Sponsors and Collaborators
Vanderbilt University
Investigators
| Principal Investigator: | John Koethe, MD | Vanderbilt University School of Medicine |
| Principal Investigator: | C. William Wester, MD | Vanderbilt University School of Medicine |
More Information
No publications provided
| Responsible Party: | John R. Koethe, Assistant Professor of Medicine, Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT01791465 History of Changes |
| Other Study ID Numbers: | 121342, P30AI054999 |
| Study First Received: | February 11, 2013 |
| Last Updated: | February 13, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Vanderbilt University:
|
HIV Diabetes |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome HIV Infections Diabetes Mellitus Immunologic Deficiency Syndromes Virus Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Slow Virus Diseases Immune System Diseases Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Exenatide Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013