Trial Outcomes & Findings for Mechanisms of Ramipril Reduction in the Onset of Type 2 Diabetes (NCT NCT00574834)
NCT ID: NCT00574834
Last Updated: 2019-09-12
Results Overview
Measures of change in endogenous glucose production from baseline to final 30 minutes of clamp studies after 6 months of treatment.
Recruitment status
TERMINATED
Study phase
EARLY_PHASE1
Target enrollment
17 participants
Primary outcome timeframe
6 months
Results posted on
2019-09-12
Participant Flow
Individuals with pre-diabetes (metabolic syndrome) are recruited for a 6 month study intervention.
Participant milestones
| Measure |
Ramipril
Patients randomized to 6 months treatment of Ramipril.
Ramipril: Ramipril 20 mg once daily for 6 months
|
HCTZ
Patients randomized to 6 months treatment of HCTZ.
HCTZ-hydrochlorothiazide: HCTZ 25 mg once daily for 6 months
|
Ramipril+HCTZ
Patients randomized to 6 months treatment of Ramipril+HCTZ.
Ramipril+HCTZ: Ramipril 20 mg and HCTZ 25 mg, both once daily for 6 months
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
4
|
4
|
|
Overall Study
COMPLETED
|
9
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mechanisms of Ramipril Reduction in the Onset of Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Ramipril
n=9 Participants
Patients randomized to 6 months treatment of Ramipril.
Ramipril: Ramipril 20 mg once daily for 6 months
|
HCTZ
n=4 Participants
Patients randomized to 6 months treatment of HCTZ.
HCTZ-hydrochlorothiazide: HCTZ 25 mg once daily for 6 months
|
Ramipril+HCTZ
n=4 Participants
Patients randomized to 6 months treatment of Ramipril+HCTZ.
Ramipril+HCTZ: Ramipril 20 mg and HCTZ 25 mg, both once daily for 6 months
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
49 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
46 years
STANDARD_DEVIATION 9 • n=7 Participants
|
41 years
STANDARD_DEVIATION 13 • n=5 Participants
|
46 years
STANDARD_DEVIATION 10 • n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
17 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 6 monthsMeasures of change in endogenous glucose production from baseline to final 30 minutes of clamp studies after 6 months of treatment.
Outcome measures
| Measure |
Ramipril
n=9 Participants
Patients randomized to 6 months treatment of Ramipril.
Ramipril: Ramipril 20 mg once daily for 6 months
|
HCTZ
n=4 Participants
Patients randomized to 6 months treatment of HCTZ.
HCTZ-hydrochlorothiazide: HCTZ 25 mg once daily for 6 months
|
Ramipril+HCTZ
n=4 Participants
Patients randomized to 6 months treatment of Ramipril+HCTZ.
Ramipril+HCTZ: Ramipril 20 mg and HCTZ 25 mg, both once daily for 6 months
|
|---|---|---|---|
|
Changes in Insulin Sensitivity
|
0.98 mg/kg/min
Standard Error 0.36
|
1.5 mg/kg/min
Standard Error 0.23
|
1.2 mg/kg/min
Standard Error 0.17
|
Adverse Events
Ramipril
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
HCTZ
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ramipril+HCTZ
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Stephen N. Davis, MBBS- Principal Investigator
University of Maryland Baltimore
Phone: 410-328-2488
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Results of this trial were too preliminary to report. Trial was ended due to lack of funding to complete. No conclusions could be drawn from existing data.
- Publication restrictions are in place
Restriction type: OTHER