Supplementation With Conjugated Linoleic Acid (CLA) as Complementary Therapy in the Management of Type 2 Diabetes Mellitus (Women's Diabetes Study) (WDS)
Status
Conditions
Treatments
Details and patient eligibility
About
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).
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
55 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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