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

Primary Purpose

Human Immunodeficiency Virus Infection, Diabetes Mellitus

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
extended-release exenatide
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Human Immunodeficiency Virus Infection focused on measuring HIV, Diabetes

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Vanderbilt University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bydureon treatment

Arm Description

Treatment for 16 weeks with extended-release Exenatide (Bydureon)

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Serum Soluble Tumor Necrosis Factor Alpha (TNF-α) Levels at Baseline and 16 Weeks
Serum Macrophage Chemotactic Protein-1 (MCP-1) Levels at Baseline and 16 Weeks
Serum Macrophage Inflammatory Protein 1 Alpha (MIP-1 Alpha) Levels at 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.
Serum Adipokine Leptin Levels at Baseline and 16 Weeks
Body Mass Index at Baseline and 16 Weeks
Serum TNF-a Receptor 1 Levels at Baseline and 16 Weeks
Serum Soluble CD14 Levels at Baseline and 16 Weeks
Serum TNF-a Receptor 2 Levels at Baseline and 16 Weeks
Serum Hemoglobin A1c (HbA1c) Levels at Baseline and 16 Weeks
Serum Triglycerides Levels at Baseline and 16 Weeks
Serum Total Cholesterol Levels at Baseline and 16 Weeks
Serum HDL Cholesterol Levels at Baseline and 16 Weeks
Serum LDL Cholesterol Levels at Baseline and 16 Weeks
Body Weight at Baseline and 16 Weeks
Waist Circumference at Baseline and 16 Weeks
Hip Circumference at Baseline and 16 Weeks
Waist to Hip Ratio at Baseline and 16 Weeks

Full Information

First Posted
February 11, 2013
Last Updated
January 20, 2017
Sponsor
Vanderbilt University
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT01791465
Brief Title
Pilot Study of Bydureon to Treat Diabetes in HIV-infected Adults
Official Title
Pilot Study of Extended-release Exenatide to Improve Glucose Control and Reduce Systemic Inflammation in Diabetic, HIV-infected Adults on Antiretroviral Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Terminated
Why Stopped
This study was terminated after 6 patients due to loss of funding
Study Start Date
March 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus Infection, Diabetes Mellitus
Keywords
HIV, Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bydureon treatment
Arm Type
Experimental
Arm Description
Treatment for 16 weeks with extended-release Exenatide (Bydureon)
Intervention Type
Drug
Intervention Name(s)
extended-release exenatide
Other Intervention Name(s)
Bydureon
Intervention Description
Single arm study - 2mg Bydureon every 7 days x 16 weeks
Primary Outcome Measure Information:
Title
Serum Highly-sensitive C-reactive Protein (hsCRP) Levels at Baseline and 16 Weeks
Description
The primary outcome will be the change in hsCRP levels from baseline (pre-treatment) to 16 weeks of Bydureon treatment.
Time Frame
baseline and 16 weeks
Title
Serum Interleukin 6 (IL-6) at Levels at Baseline and 16 Weeks
Description
The primary outcome will be the change in serum IL-6 levels from baseline (pre-treatment) to 16 weeks of Bydureon treatment.
Time Frame
baseline and 16 weeks
Secondary Outcome Measure Information:
Title
Serum Soluble Tumor Necrosis Factor Alpha (TNF-α) Levels at Baseline and 16 Weeks
Time Frame
baseline and 16 weeks
Title
Serum Macrophage Chemotactic Protein-1 (MCP-1) Levels at Baseline and 16 Weeks
Time Frame
baseline and 16 weeks
Title
Serum Macrophage Inflammatory Protein 1 Alpha (MIP-1 Alpha) Levels at Baseline and 16 Weeks
Time Frame
baseline and 16 weeks
Title
Oral Glucose Insulin Sensitivity (OGIS) at Baseline and 16 Weeks
Description
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.
Time Frame
baseline and 16 weeks
Title
Serum Adipokine Leptin Levels at Baseline and 16 Weeks
Time Frame
baseline and 16 weeks
Title
Body Mass Index at Baseline and 16 Weeks
Time Frame
16 weeks
Title
Serum TNF-a Receptor 1 Levels at Baseline and 16 Weeks
Time Frame
baseline and 16 weeks
Title
Serum Soluble CD14 Levels at Baseline and 16 Weeks
Time Frame
baseline and 16 weeks
Title
Serum TNF-a Receptor 2 Levels at Baseline and 16 Weeks
Time Frame
baseline and 16 weeks
Title
Serum Hemoglobin A1c (HbA1c) Levels at Baseline and 16 Weeks
Time Frame
baseline and 16 weeks
Title
Serum Triglycerides Levels at Baseline and 16 Weeks
Time Frame
baseline and 16 weeks
Title
Serum Total Cholesterol Levels at Baseline and 16 Weeks
Time Frame
baseline and 16 weeks
Title
Serum HDL Cholesterol Levels at Baseline and 16 Weeks
Time Frame
baseline and 16 weeks
Title
Serum LDL Cholesterol Levels at Baseline and 16 Weeks
Time Frame
baseline and 16 weeks
Title
Body Weight at Baseline and 16 Weeks
Time Frame
baseline and 16 weeks
Title
Waist Circumference at Baseline and 16 Weeks
Time Frame
baseline and 16 weeks
Title
Hip Circumference at Baseline and 16 Weeks
Time Frame
baseline and 16 weeks
Title
Waist to Hip Ratio at Baseline and 16 Weeks
Time Frame
baseline and 16 weeks
Other Pre-specified Outcome Measures:
Title
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
Description
Normal: LnRHI > 0.51 Abnormal: LnRHI ≤ 0.51
Time Frame
baseline and 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Koethe, MD
Organizational Affiliation
Vanderbilt University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
C. William Wester, MD
Organizational Affiliation
Vanderbilt University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37240
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data is protected by HIPPA and Vanderbilt University research regulations. Summary de-identified data is available if requested

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

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