Trial Outcomes & Findings for Effects of Fatty Acid Delivery on Heart Metabolism and Function in Type 2 Diabetes (T2DM (NCT NCT00577590)
NCT ID: NCT00577590
Last Updated: 2018-08-31
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
78 participants
Primary outcome timeframe
Baseline and 3 months
Results posted on
2018-08-31
Participant Flow
Participant milestones
| Measure |
Metformin and Lovaza
Participants assigned to take metformin and Lovaza
Lovaza: Dosage of 4 g to be taken daily for 2 months
Metformin: Dosage of at least 1000 mg to be taken daily for 4 months
|
Metformin
Participants assigned to take metformin and placebo
Metformin: Dosage of at least 1000 mg to be taken daily for 4 months
|
Metformin and Rosiglitazone
Patients received Metformin and Rosiglitizone
|
|---|---|---|---|
|
Overall Study
STARTED
|
28
|
27
|
23
|
|
Overall Study
COMPLETED
|
28
|
27
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Metformin and Lovaza
n=28 Participants
Participants assigned to take metformin and Lovaza
Lovaza: Dosage of 4 g to be taken daily for 2 months
Metformin: Dosage of at least 1000 mg to be taken daily for 4 months
|
Metformin
n=27 Participants
Participants assigned to take metformin and placebo
Metformin: Dosage of at least 1000 mg to be taken daily for 4 months
|
Metformin and Rosiglitizone
n=23 Participants
Participants assigned to take Metformin and Rosiglitizone
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=28 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=78 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=28 Participants
|
27 Participants
n=27 Participants
|
23 Participants
n=23 Participants
|
78 Participants
n=78 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=28 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=78 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=28 Participants
|
15 Participants
n=27 Participants
|
15 Participants
n=23 Participants
|
43 Participants
n=78 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=28 Participants
|
12 Participants
n=27 Participants
|
8 Participants
n=23 Participants
|
35 Participants
n=78 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
28 Participants
n=28 Participants
|
27 Participants
n=27 Participants
|
23 Participants
n=23 Participants
|
78 Participants
n=78 Participants
|
PRIMARY outcome
Timeframe: Baseline and 3 monthsPopulation: Data presented are stratified by sex
Outcome measures
| Measure |
Metformin
n=27 Participants
Participants assigned to take metformin and placebo
Metformin: Dosage of at least 1000 mg to be taken daily for 4 months
|
Metformin and Rosiglitazone
n=23 Participants
Patients received Metformin and Rosiglitizone
|
Metformin and Lovaza
n=28 Participants
Participants assigned to take metformin and Lovaza
Lovaza: Dosage of 4 g to be taken daily for 2 months
Metformin: Dosage of at least 1000 mg to be taken daily for 4 months
|
|---|---|---|---|
|
Percent Change in Plasma Triglycerides
Plasma triglycerides women
|
16.0 percent change
Standard Deviation 30
|
-5.0 percent change
Standard Deviation 15
|
-2.0 percent change
Standard Deviation 12
|
|
Percent Change in Plasma Triglycerides
Plasma triglycerides men
|
-10.0 percent change
Standard Deviation 5
|
1.0 percent change
Standard Deviation 12
|
-5.0 percent change
Standard Deviation 12
|
Adverse Events
Metformin and Lovaza
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Metformin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Metformin and Rosiglitizone
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
Robert Gropler, MD, Chief of Cardiovascular Imaging Laboratory
Washington University School of Medicine
Phone: 314-747-3877
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place