|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 October 2017 |
|
Main ID: |
NCT01612858 |
|
Date of registration:
|
04/06/2012 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Metabolic Abnormalities in HIV-infected Persons
|
|
Scientific title:
|
Metabolic Abnormalities in HIV-infected Persons |
|
Date of first enrolment:
|
June 2011 |
|
Target sample size:
|
20 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT01612858 |
|
Study type:
|
Interventional |
|
Study design:
|
|
|
Phase:
|
Phase 4
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Rakhi Kohli, MD, MS |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Tufts Medical Center |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Age 18-70 years
- Fasting insulin >12 µU/mL and/or serum glucose between 140-200 mg/dl after 75 g 2hr
oral glucose tolerance test
- Central fat deposition or Peripheral fat atrophy
- Fasting glucose =126 mg/dL
- BMI =18 and =35 kg/m2
- CD4 cell count =100 cells/mm3
- Stable antiretroviral regimen =12 weeks and HIV RNA <1000 copies
Exclusion Criteria:
- Diabetes mellitus
- Cardiac pacemaker or metal implant
- Liver enzymes >2.5x upper normal limit
- Alkaline phosphatase or prothrombin time >2x upper normal limit
- Serum creatinine >1.4 mg/dL
- History of congestive heart failure
- Hemoglobin <8 g/dL
- Alcohol abuse
- Pregnancy
- History of lactic acidosis
- Use of steroids
- Acute infection within last one month
- History of bladder cancer
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
HIV Infection
|
|
Lipodystrophy
|
|
Intervention(s)
|
|
Drug: Metformin
|
|
Drug: Pioglitazone
|
|
Primary Outcome(s)
|
|
Change in Insulin Sensitivity From Baseline to Week 12 Post-treatment With Insulin Sensitizing Agent
[Time Frame: 3 months]
|
|
Secondary Outcome(s)
|
|
Change in Hepatic Fat From Baseline to Week 12 Post-treatment With an Insulin Sensitizing Agent
[Time Frame: 12 weeks]
|
|
Secondary ID(s)
|
|
1K23DK079789-01A2
|
|
CLAMP-K23
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|