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Clinical Trial Details

Trial ID: L7104
Source ID: NCT00607945
Associated Drug: Rosiglitazone (Avandia) Or Other Diabetes Medication Currently Prescribed To Participant
Title: Dietary Fatty Acids As Complementary Therapy in Type 2 Diabetes Mellitus
Acronym: FACT
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Rosiglitazone (Avandia) OR other diabetes medication currently prescribed to participant|DIETARY_SUPPLEMENT: conjugated linoleic acid (CLA)|DIETARY_SUPPLEMENT: conjugated linoleic acid (CLA)
Outcome Measures: Primary: Difference in change in body weight of the intervention groups, Between baseline and week 32, or end of study | Secondary: Change in fat mass, Between baseline and week 32|Change in lean mass, Between baseline and week 32|Change in insulin sensitivity, Between week 0 and week 32|Change in lipid profile (TChol, LDL, HDL, C-reactive protein), Weeks -4, -1, 0, 8, 16, 24, 31, 32|Changes in adipocytokine profile (leptin, adiponectin, visfatin, and resistin), Weeks -4, -1, 0, 8, 16, 24, 31, 32|Changes in liver enzymes (ALT and AST), Weeks -4, -1, 0, 8, 16, 24, 31, 32|Edema, Weeks -4, -1, 0, 8, 16, 24, 31, 32|Change in glucose control, Weeks -1, 16, 31|Change in bone density, bone formation and resorption markers, Weeks -4, -1, 31|Change in C-Peptide, Weeks - 4, -1, 0, 1, 8, 16, 24, 31, 32|Diabetes coping behaviors and self-efficacy, Weeks -4, -1, 32|Chronic stress (as measured by questionnaire), Weeks -4 and 32|Appetite (as measured by appetite rating scale), Weeks -4, 0, 16, 32|EKG, Weeks -4, 16, 32|BNP (brain type natriuretic peptide), Weeks -4 and 32|Energy balance (physical activity recalls, food records, indirect calorimetry), Weeks -1, 16, 31|Compliance (fatty acid composition, pill counts), Weeks -1, 0, 8, 16, 24, 31, 32|Nutrition knowledge, Weeks -4, 0, 32
Sponsor/Collaborators: Sponsor: Ohio State University | Collaborators: National Center for Complementary and Integrative Health (NCCIH)|GlaxoSmithKline|Bunge Loders Croklaan|LifeScan
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 48
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2008-01
Completion Date: 2012-05
Results First Posted:
Last Update Posted: 2024-10-29
Locations: The Ohio State University Clinical Research Center (Davis Medical Research Center), Columbus, Ohio, 43210, United States
URL: https://clinicaltrials.gov/show/NCT00607945