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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01791465
Other study ID # 121342
Secondary ID P30AI054999
Status Completed
Phase Phase 4
First received February 11, 2013
Last updated December 19, 2014
Start date March 2013
Est. completion date December 2014

Study information

Verified date December 2014
Source Vanderbilt University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
extended-release exenatide


Locations

Country Name City State
United States Vanderbilt University Nashville Tennessee

Sponsors (2)

Lead Sponsor Collaborator
Vanderbilt University National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

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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