Diabetes Mellitus
Conditions
Keywords
diabetes, conjugated linoleic acid
Brief summary
The purpose of this study is to determine the role of CLA as a complementary therapy to improve body composition, glucose tolerance, fasting plasma glucose and insulin, and hemoglobinA1c (HbA1c) in subjects with type 2 diabetes mellitus (T2DM).
Detailed description
The design is a double-blind, placebo-controlled, crossover study conducted at a single site. The primary variable is a change from baseline to Week 16 in plasma glucose area under the curve during a three-hour oral glucose tolerance test. Secondary variables include changes in fasting levels of glucose and insulin, glucose tolerance, hemoglobinA1c, hepatic enzymes, adipocytokines, blood lipid profile, and body composition. Supporting endpoints include dietary intake, physical activity, fatty acids, and vital signs.
Interventions
DIETARY_SUPPLEMENTConjugated Linoleic Acid (CLA)
6.4 g CLA/day, capsule form, for 16 week arms
DIETARY_SUPPLEMENTSafflower OIl
8.0g/day safflower oil
Sponsors
Cognis
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* diagnosis of Type 2 diabetes mellitus * obese * postmenopausal * HbA1c \>6.49 and \<14.1
Exclusion criteria
* use of tobacco * substance abuse * impaired cognitive function * renal disease * abnormal liver function * gastrointestinal diseases * use of exogenous insulin * use of hormone replacement therapy currently or within past 6 months * pacemaker/defibrillator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in plasma glucose AUC | baseline and week 16 | significant change in plasma glucose AUC (0-3 h) from baseline to Week 16. |
Secondary
| Measure | Time frame |
|---|---|
| change in body composition | baseline and every 4 weeks for 16 weeks |
| change in insulin sensitivity | baseline and every 4 weeks until week 16 |
| change in glucose tolerance | baseline and every 4 weeks for 16 weeks |
| change in hepatic enzymes | baseline and every 4 weeks for 16 weeks |
| change in blood lipid profile | baseline and every 4 weeks for 16 weeks |
| change in serum adipocytokines | baseline and every 4 weeks for 16 weeks |
| change in HbA1c | baseline and week 16 |
Countries
United States
Outcome results
None listed