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Clinical trial

Dietary Fatty Acids as Complementary Therapy in Type 2 Diabetes Mellitus

ID
Name
2007H0185
Description
The purpose of the study is to see how a dietary oil called conjugated linoleic acid, or CLA, might be useful in combination with diabetes medication. Some studies show that CLA can modestly reduce body weight and body fat. Our research idea is that taking CLA will reduce body weight and body fat without interfering with the diabetes medications' effects on blood sugar.
Trial arms
Trial start
2008-01-01
Estimated PCD
2012-05-01
Trial end
2012-05-01
Status
Completed
Phase
Early phase I
Treatment
Rosiglitazone (Avandia) OR other diabetes medication currently prescribed to participant
Rosiglitazone 4-8mg/day, pill, from week -4 to week 32 OR other diabetes medication taken as prescribed from week -4 to week 32
Arms:
0 g CLA, 3.2 g CLA, 6.4 g CLA
Other names:
Avandia
conjugated linoleic acid (CLA)
3.2 g/day, capsule, week 0 to week 32
Arms:
3.2 g CLA
Other names:
Tonalin, Clarinol
conjugated linoleic acid (CLA)
6.4 g/day, capsule, week 0 to week 32
Arms:
6.4 g CLA
Other names:
Tonalin, Clarinol
Size
48
Primary endpoint
Difference in change in body weight of the intervention groups
Between baseline and week 32, or end of study
Eligibility criteria
Inclusion Criteria: * Diagnosis of type 2 diabetes mellitus * HbA1c ≤ 9% * Overweight or obese (BMI ≥ 25 kg/m2 and ≤ 45 kg/m2) * Age ≥ 30 and ≤ 70 years (postmenopausal if female) * Stable medical therapy for past 3 months * Stable body weight (within ± 2 kg) for past 3 months * Plans to remain in the Columbus, OH metropolitan area for at least 1 year Exclusion Criteria: * Substance abuse * Current use of prescription or over-the-counter medications or supplements known to affect body composition * Current use of prescription or over-the-counter medications or supplements known to interact with thiazolidinediones(TZDs) * Current or previous diagnosis of congestive heart failure * Self-report of claustrophobia * Abnormal liver function * Impaired cognitive function * Current or previous diagnosis of renal disease * Gastrointestinal diseases or disorders * Current use of hormone therapies, or use within the past 3 months * Discontinuation of diabetes medication
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 48, 'type': 'ACTUAL'}}
Updated at
2023-10-10

1 organization

1 product

1 indication

Organization
Ohio State University
Product
Rosiglitazone
Indication
Type 2 Diabetes Mellitus