Dietary Fatty Acids As Complementary Therapy in Type 2 Diabetes Mellitus

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.

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