Trial Outcomes & Findings for Metabolic Abnormalities in HIV-infected Persons (NCT NCT01612858)
NCT ID: NCT01612858
Last Updated: 2016-06-20
Results Overview
Change in insulin sensitivity measured by 2 hour euglycemic-hyperinsulinemic clamp from baseline to week 12 post treatment with metformin or pioglitazone
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
20 participants
Primary outcome timeframe
3 months
Results posted on
2016-06-20
Participant Flow
Participant milestones
| Measure |
Metformin
Metformin: Metformin at a dose of one 500mg tablet twice a day with meals for one week, after which the dose will increase to 500 mg three times a day with meals for the remaining 11 weeks of the study.
|
Pioglitazone
Pioglitazone: Pioglitazone at a dose of one 30 mg tablet once per day for the 12 weeks of the study.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
4
|
|
Overall Study
COMPLETED
|
11
|
3
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
Reasons for withdrawal
| Measure |
Metformin
Metformin: Metformin at a dose of one 500mg tablet twice a day with meals for one week, after which the dose will increase to 500 mg three times a day with meals for the remaining 11 weeks of the study.
|
Pioglitazone
Pioglitazone: Pioglitazone at a dose of one 30 mg tablet once per day for the 12 weeks of the study.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
1
|
Baseline Characteristics
Metabolic Abnormalities in HIV-infected Persons
Baseline characteristics by cohort
| Measure |
Metformin
n=16 Participants
Metformin: Metformin at a dose of one 500mg tablet twice a day with meals for one week, after which the dose will increase to 500 mg three times a day with meals for the remaining 11 weeks of the study.
|
Pioglitazone
n=4 Participants
Pioglitazone: Pioglitazone at a dose of one 30 mg tablet once per day for the 12 weeks of the study.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.9 years
STANDARD_DEVIATION 7.9 • n=99 Participants
|
55.7 years
STANDARD_DEVIATION 8.6 • n=107 Participants
|
54.2 years
STANDARD_DEVIATION 7.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Only participants with baseline and post insulin-sensitizing treatment euglycemic-hyperinsulinemic clamp were included in this analysis
Change in insulin sensitivity measured by 2 hour euglycemic-hyperinsulinemic clamp from baseline to week 12 post treatment with metformin or pioglitazone
Outcome measures
| Measure |
Metformin
n=11 Participants
Metformin: Metformin at a dose of one 500mg tablet twice a day with meals for one week, after which the dose will increase to 500 mg three times a day with meals for the remaining 11 weeks of the study.
|
Pioglitazone
n=3 Participants
Pioglitazone: Pioglitazone at a dose of one 30 mg tablet once per day for the 12 weeks of the study.
|
|---|---|---|
|
Change in Insulin Sensitivity From Baseline to Week 12 Post-treatment With Insulin Sensitizing Agent
|
-0.25 mg/kg lean body mass/min
Standard Deviation 1.98
|
-0.96 mg/kg lean body mass/min
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Only participants with baseline and post insulin sensitizing treatment magnetic resonance spectrosocpy were included in this analysis.
Change in hepatic fat was measured after 12 weeks of treatment with metformin or pioglitazone using magnetic resonance spectroscopy
Outcome measures
| Measure |
Metformin
n=11 Participants
Metformin: Metformin at a dose of one 500mg tablet twice a day with meals for one week, after which the dose will increase to 500 mg three times a day with meals for the remaining 11 weeks of the study.
|
Pioglitazone
n=3 Participants
Pioglitazone: Pioglitazone at a dose of one 30 mg tablet once per day for the 12 weeks of the study.
|
|---|---|---|
|
Change in Hepatic Fat From Baseline to Week 12 Post-treatment With an Insulin Sensitizing Agent
|
2.30 percentage of hepatic fat
Standard Deviation 2.10
|
-2.56 percentage of hepatic fat
Standard Deviation 1.16
|
Adverse Events
Metformin
Serious events: 7 serious events
Other events: 4 other events
Deaths: 0 deaths
Pioglitazone
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Metformin
n=16 participants at risk
Metformin: Metformin at a dose of one 500mg tablet twice a day with meals for one week, after which the dose will increase to 500 mg three times a day with meals for the remaining 11 weeks of the study.
|
Pioglitazone
n=4 participants at risk
Pioglitazone: Pioglitazone at a dose of one 30 mg tablet once per day for the 12 weeks of the study.
|
|---|---|---|
|
Gastrointestinal disorders
Colitis
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected for three months.
|
0.00%
0/4 • Adverse event data were collected for three months.
|
|
Renal and urinary disorders
Elevated serum creatinine
|
12.5%
2/16 • Number of events 2 • Adverse event data were collected for three months.
|
0.00%
0/4 • Adverse event data were collected for three months.
|
|
Metabolism and nutrition disorders
Elevated lactic acid
|
12.5%
2/16 • Number of events 2 • Adverse event data were collected for three months.
|
0.00%
0/4 • Adverse event data were collected for three months.
|
|
Gastrointestinal disorders
Right upper quadrant abdominal pain
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected for three months.
|
0.00%
0/4 • Adverse event data were collected for three months.
|
|
Nervous system disorders
Head trauma accompanied by syncope
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected for three months.
|
0.00%
0/4 • Adverse event data were collected for three months.
|
Other adverse events
| Measure |
Metformin
n=16 participants at risk
Metformin: Metformin at a dose of one 500mg tablet twice a day with meals for one week, after which the dose will increase to 500 mg three times a day with meals for the remaining 11 weeks of the study.
|
Pioglitazone
n=4 participants at risk
Pioglitazone: Pioglitazone at a dose of one 30 mg tablet once per day for the 12 weeks of the study.
|
|---|---|---|
|
Gastrointestinal disorders
Bloating
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected for three months.
|
0.00%
0/4 • Adverse event data were collected for three months.
|
|
Gastrointestinal disorders
diarrhea
|
18.8%
3/16 • Number of events 3 • Adverse event data were collected for three months.
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected for three months.
|
|
Gastrointestinal disorders
vomiting
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected for three months.
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected for three months.
|
|
Gastrointestinal disorders
nausea
|
12.5%
2/16 • Number of events 2 • Adverse event data were collected for three months.
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected for three months.
|
|
Musculoskeletal and connective tissue disorders
Baker's cyst
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected for three months.
|
0.00%
0/4 • Adverse event data were collected for three months.
|
|
Infections and infestations
tooth pain
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected for three months.
|
0.00%
0/4 • Adverse event data were collected for three months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place