Clinical trial NCT00607945: Dietary Fatty Acids As Complementary Therapy in Type 2 Diabetes Mellitus
Official title: Dietary Fatty Acids As Complementary Therapy in Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 diabetes mellitus
conjugated linoleic acid
weight loss
rosiglitazone
glucose control
insulin sensitivity
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
name: GlaxoSmithKline
name: Bunge Loders Croklaan
name: LifeScan
First posted: 2008-02-06
Enrollment: 48
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference in change in body weight of the intervention groups
timeFrame: Between baseline and week 32, or end of study
Secondary outcomes:
measure: Change in fat mass
timeFrame: Between baseline and week 32
measure: Change in lean mass
timeFrame: Between baseline and week 32
measure: Change in insulin sensitivity
timeFrame: Between week 0 and week 32
measure: Change in lipid profile (TChol, LDL, HDL, C-reactive protein)
timeFrame: Weeks -4, -1, 0, 8, 16, 24, 31, 32
measure: Changes in adipocytokine profile (leptin, adiponectin, visfatin, and resistin)
timeFrame: Weeks -4, -1, 0, 8, 16, 24, 31, 32
measure: Changes in liver enzymes (ALT and AST)
timeFrame: Weeks -4, -1, 0, 8, 16, 24, 31, 32
measure: Edema
timeFrame: Weeks -4, -1, 0, 8, 16, 24, 31, 32
measure: Change in glucose control
timeFrame: Weeks -1, 16, 31
measure: Change in bone density, bone formation and resorption markers
timeFrame: Weeks -4, -1, 31
measure: Change in C-Peptide
timeFrame: Weeks - 4, -1, 0, 1, 8, 16, 24, 31, 32
measure: Diabetes coping behaviors and self-efficacy
timeFrame: Weeks -4, -1, 32
measure: Chronic stress (as measured by questionnaire)
timeFrame: Weeks -4 and 32
measure: Appetite (as measured by appetite rating scale)
timeFrame: Weeks -4, 0, 16, 32
measure: EKG
timeFrame: Weeks -4, 16, 32
measure: BNP (brain type natriuretic peptide)
timeFrame: Weeks -4 and 32
measure: Energy balance (physical activity recalls, food records, indirect calorimetry)
timeFrame: Weeks -1, 16, 31
measure: Compliance (fatty acid composition, pill counts)
timeFrame: Weeks -1, 0, 8, 16, 24, 31, 32
measure: Nutrition knowledge
timeFrame: Weeks -4, 0, 32
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Clinical Research Center (Davis Medical Research Center)
state: Ohio
Study officials:
affiliation: Ohio State University
name: Martha A Belury, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References: