A Phase 1 interventional study of Rosiglitazone (Avandia) OR other diabetes medication currently prescribed to participant and conjugated linoleic acid (CLA) in Type 2 Diabetes Mellitus, sponsored by Ohio State University. Completed at 1 site in United States. Open to participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-10-29.
Sponsored by Ohio State University · Phase 1, Interventional, and Treatment
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.
The long term goal of this research is to develop effective complementary strategies to aid in the management of type 2 diabetes (T2DM). Our central hypothesis is that CLA reduces body weight and body fat mass when administered concomitantly with oral diabetes medication, The rationale of this study is that using CLA to reduce body weight and body fat in people with T2DM may improve efficacy and longevity of the oral diabetes medications in the management of T2DM. We plan to test our central hypothesis and accomplish the overall objective of this research by pursuing the following three specific aims.
Specific Aim 1: Determine the ability of CLA to reduce body weight and body fat mass in people using oral diabetes medication for management of T2DM.
Specific Aim 2: Determine the ability of CLA to modulate insulin sensitivity when combined with oral diabetes medication.
Specific Aim 3: Determine the safety and tolerability of CLA in combination with oral diabetes medication.
9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.
This study's enrollment of 48 is below the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Ohio State University is the lead sponsor of 658 studies on the registry; 145 are open to participants now.
Of its 66 completed or terminated interventional studies of FDA-regulated products, 49 (74%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Avandia (Rosiglitazone) 4-8mg/day OR other diabetes medication currently prescribed to participant, 0 g CLA, 8 g Placebo oil (based on typical American diet)
Drug: Rosiglitazone (Avandia) OR other diabetes medication currently prescribed to participant
Avandia 4-8mg/day OR other diabetes medication currently prescribed to participant, 3.2 g CLA, 4.8 g placebo oil (based on typical American diet)
Drug: Rosiglitazone (Avandia) OR other diabetes medication currently prescribed to participant · Dietary Supplement: conjugated linoleic acid (CLA)
Avandia 4-8mg/day OR other diabetes medication currently prescribed to participant, 6.4 g CLA, 1.6 g placebo oil (based on typical American diet)
Drug: Rosiglitazone (Avandia) OR other diabetes medication currently prescribed to participant · Dietary Supplement: conjugated linoleic acid (CLA)
Rosiglitazone 4-8mg/day, pill, from week -4 to week 32 OR other diabetes medication taken as prescribed from week -4 to week 32
Also known as: Avandia
3.2 g/day, capsule, week 0 to week 32
Also known as: Tonalin, Clarinol
6.4 g/day, capsule, week 0 to week 32
Also known as: Tonalin, Clarinol
Difference in change in body weight of the intervention groups
Time frame: Between baseline and week 32, or end of study
Change in fat mass
Time frame: Between baseline and week 32
Change in lean mass
Time frame: Between baseline and week 32
Change in insulin sensitivity
Time frame: Between week 0 and week 32
Change in lipid profile (TChol, LDL, HDL, C-reactive protein)
Time frame: Weeks -4, -1, 0, 8, 16, 24, 31, 32
Changes in adipocytokine profile (leptin, adiponectin, visfatin, and resistin)
Time frame: Weeks -4, -1, 0, 8, 16, 24, 31, 32
Changes in liver enzymes (ALT and AST)
Time frame: Weeks -4, -1, 0, 8, 16, 24, 31, 32
Edema
Time frame: Weeks -4, -1, 0, 8, 16, 24, 31, 32
Change in glucose control
Time frame: Weeks -1, 16, 31
Change in bone density, bone formation and resorption markers
Time frame: Weeks -4, -1, 31
Change in C-Peptide
Time frame: Weeks - 4, -1, 0, 1, 8, 16, 24, 31, 32
Diabetes coping behaviors and self-efficacy
Time frame: Weeks -4, -1, 32
Chronic stress (as measured by questionnaire)
Time frame: Weeks -4 and 32
Appetite (as measured by appetite rating scale)
Time frame: Weeks -4, 0, 16, 32
EKG
Time frame: Weeks -4, 16, 32
BNP (brain type natriuretic peptide)
Time frame: Weeks -4 and 32
Energy balance (physical activity recalls, food records, indirect calorimetry)
Time frame: Weeks -1, 16, 31
Compliance (fatty acid composition, pill counts)
Time frame: Weeks -1, 0, 8, 16, 24, 31, 32
Nutrition knowledge
Time frame: Weeks -4, 0, 32
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Linoleic Acids, Conjugated