Dietary Fatty Acids as Complementary Therapy in Type 2 Diabetes Mellitus

Official Title: “Dietary Fatty Acids as Complementary Therapy in Type 2 Diabetes Mellitus”

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.

Intervention(s) in this Clinical Trial

• Drug: 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
• Dietary Supplement: conjugated linoleic acid (CLA)
  • 3.2 g/day, capsule, week 0 to week 32
• Dietary Supplement: conjugated linoleic acid (CLA)
  • 6.4 g/day, capsule, week 0 to week 32

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: 0 g CLA
  • 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)
• Experimental: 3.2 g CLA
  • 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)
• Experimental: 6.4 g 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)

Primary Measures

• Difference in change in body weight of the intervention groups
  • Time Frame: Between baseline and week 32, or end of study
    Safety Issue?: No

Secondary Measures

• Change in fat mass
  • Time Frame: Between baseline and week 32
    Safety Issue?: No
• Change in lean mass
  • Time Frame: Between baseline and week 32
    Safety Issue?: No
• Change in insulin sensitivity
  • Time Frame: Between week 0 and week 32
    Safety Issue?: No
• Change in lipid profile (TChol, LDL, HDL, C-reactive protein)
  • Time Frame: Weeks -4, -1, 0, 8, 16, 24, 31, 32
    Safety Issue?: Yes
• Changes in adipocytokine profile (leptin, adiponectin, visfatin, and resistin)
  • Time Frame: Weeks -4, -1, 0, 8, 16, 24, 31, 32
    Safety Issue?: No
• Changes in liver enzymes (ALT and AST)
  • Time Frame: Weeks -4, -1, 0, 8, 16, 24, 31, 32
    Safety Issue?: Yes
• Edema
  • Time Frame: Weeks -4, -1, 0, 8, 16, 24, 31, 32
    Safety Issue?: Yes
• Change in glucose control
  • Time Frame: Weeks -1, 16, 31
    Safety Issue?: No
• Change in bone density, bone formation and resorption markers
  • Time Frame: Weeks -4, -1, 31
    Safety Issue?: No
• Change in C-Peptide
  • Time Frame: Weeks - 4, -1, 0, 1, 8, 16, 24, 31, 32
    Safety Issue?: No
• Diabetes coping behaviors and self-efficacy
  • Time Frame: Weeks -4, -1, 32
    Safety Issue?: No
• Chronic stress (as measured by questionnaire)
  • Time Frame: Weeks -4 and 32
    Safety Issue?: No
• Appetite (as measured by appetite rating scale)
  • Time Frame: Weeks -4, 0, 16, 32
    Safety Issue?: No
• EKG
  • Time Frame: Weeks -4, 16, 32
    Safety Issue?: Yes
• BNP (brain type natriuretic peptide)
  • Time Frame: Weeks -4 and 32
    Safety Issue?: Yes
• Energy balance (physical activity recalls, food records, indirect calorimetry)
  • Time Frame: Weeks -1, 16, 31
    Safety Issue?: No
• Compliance (fatty acid composition, pill counts)
  • Time Frame: Weeks -1, 0, 8, 16, 24, 31, 32
    Safety Issue?: No
• Nutrition knowledge
  • Time Frame: Weeks -4, 0, 32
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 30 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Ohio State University Other

Overall Clinical Trial Officials and Contacts

Martha A Belury, PhD, RD Principal Investigator The Ohio State University Department of Human Nutrition  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00607945

Study ID Number: 2007H0185

ClinicalTrials.gov Identifier: NCT00607945

Health Authority: United States: Federal Government

The Ohio State University College of Education and Human Ecology Clinical Studies Website