Pilot Study of Bydureon to Treat Diabetes in HIV-infected Adults

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2013 by Vanderbilt University
Sponsor:
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on July 31, 2014