Type 2 Diabetes Mellitus
Conditions
Keywords
Type 2 diabetes mellitus, conjugated linoleic acid, weight loss, rosiglitazone, glucose control, insulin sensitivity
Brief summary
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.
Detailed 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.
Interventions
DIETARY_SUPPLEMENTconjugated linoleic acid (CLA)
3.2 g/day, capsule, week 0 to week 32
DRUGRosiglitazone (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
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
GlaxoSmithKline
Bunge Loders Croklaan
LifeScan
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in change in body weight of the intervention groups | Between baseline and week 32, or end of study |
Secondary
| Measure | Time frame |
|---|---|
| Edema | Weeks -4, -1, 0, 8, 16, 24, 31, 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 |
| 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 glucose control | Weeks -1, 16, 31 |
| Change in bone density, bone formation and resorption markers | Weeks -4, -1, 31 |
| Changes in liver enzymes (ALT and AST) | Weeks -4, -1, 0, 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 |
| Change in C-Peptide | Weeks - 4, -1, 0, 1, 8, 16, 24, 31, 32 |
Countries
United States
Outcome results
None listed