Diabetes Mellitus Clinical Trial
Official title:
Pilot Study of Extended-release Exenatide to Improve Glucose Control and Reduce Systemic Inflammation in Diabetic, HIV-infected Adults on Antiretroviral Therapy
Verified date | December 2014 |
Source | Vanderbilt University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 6 |
Est. completion date | December 2014 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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) |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University | National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | The change from baseline to 16 weeks in peripheral endothelial tonography, as measured by the non-invasive EndoPAT system | 16 weeks | No | |
Primary | Change in serum interleukin 6 (IL-6) and highly-sensitive C-reactive protein (hsCRP) levels | The primary outcome will be the change in serum IL-6 and hsCRP levels from baseline (pre-treatment) to 16 weeks of Bydureon treatment. | 16 weeks | No |
Secondary | Change from baseline to 16 weeks in serum levels of soluble tumor necrosis factor alpha (TNF-a) receptor 1 & 2, cystatin C, macrophage chemotactic protein-1 (MCP-1), macrophage inflammatory protein 1 alpha (MIP-1a), and interleukin 1 beta (IL-1ß) | 16 weeks | No | |
Secondary | The change from baseline to 16 weeks in the response to an oral glucose tolerance challenge and in serum hemoglobin A1c levels | 16 weeks | No | |
Secondary | The change from baseline to 16 weeks in serum LDL cholesterol, HDL cholesterol, total cholesterol, & triglycerides | 16 weeks | No | |
Secondary | The change from baseline to 16 weeks in serum adipokine (leptin and adiponectin) levels | 16 weeks | No | |
Secondary | The change from baseline to 16 weeks in body fat mass and distribution, anthropometrics, and body mass index | 16 weeks | No |
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