Dietary Fatty Acids As Complementary Therapy in Type 2 Diabetes Mellitus (FACT)

The Ohio State University

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Dietary Supplement: conjugated linoleic acid (CLA); Drug: Rosiglitazone (Avandia) OR other diabetes medication currently prescribed to participant

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT00607945

2007H0185

R21AT003520-01A2 (U.S. NIH Grant/Contract)

5R21AT003520 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 48 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 3 patient groups, including a placebo group

0 g CLA

Placebo Comparator group

Description:

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)

Treatment:

Drug: Rosiglitazone (Avandia) OR other diabetes medication currently prescribed to participant

3.2 g CLA

Experimental group

Description:

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)

Treatment:

Drug: Rosiglitazone (Avandia) OR other diabetes medication currently prescribed to participant

Dietary Supplement: conjugated linoleic acid (CLA)

Dietary Supplement: conjugated linoleic acid (CLA)

6.4 g CLA

Experimental group

Description:

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)

Treatment:

Drug: Rosiglitazone (Avandia) OR other diabetes medication currently prescribed to participant

Dietary Supplement: conjugated linoleic acid (CLA)

Dietary Supplement: conjugated linoleic acid (CLA)