Dietary Fatty Acids as Complementary Therapy in Type 2 Diabetes Mellitus

Type 2 Diabetes Mellitus Clinical Trial

— FACT  

Official title:

Dietary Fatty Acids as Complementary Therapy in Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00607945
• Other study ID #: 2007H0185
• Secondary ID: R21AT003520-01A2
• Status: Completed
• Phase: Phase 1
• Start date: January 2008
• Est. completion date: May 2012

Study information

• Verified date: October 2023
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

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
• conjugated linoleic acid (CLA)
6.4 g/day, capsule, week 0 to week 32

Locations

Country	Name	City	State
United States	The Ohio State University Clinical Research Center (Davis Medical Research Center)	Columbus	Ohio

Sponsors (5)

Lead Sponsor	Collaborator
Ohio State University	Bunge Loders Croklaan, GlaxoSmithKline, LifeScan, National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in change in body weight of the intervention groups		Between baseline and week 32, or end of study
Secondary	Change in fat mass		Between baseline and week 32
Secondary	Change in lean mass		Between baseline and week 32
Secondary	Change in insulin sensitivity		Between week 0 and week 32
Secondary	Change in lipid profile (TChol, LDL, HDL, C-reactive protein)		Weeks -4, -1, 0, 8, 16, 24, 31, 32
Secondary	Changes in adipocytokine profile (leptin, adiponectin, visfatin, and resistin)		Weeks -4, -1, 0, 8, 16, 24, 31, 32
Secondary	Changes in liver enzymes (ALT and AST)		Weeks -4, -1, 0, 8, 16, 24, 31, 32
Secondary	Edema		Weeks -4, -1, 0, 8, 16, 24, 31, 32
Secondary	Change in glucose control		Weeks -1, 16, 31
Secondary	Change in bone density, bone formation and resorption markers		Weeks -4, -1, 31
Secondary	Change in C-Peptide		Weeks - 4, -1, 0, 1, 8, 16, 24, 31, 32
Secondary	Diabetes coping behaviors and self-efficacy		Weeks -4, -1, 32
Secondary	Chronic stress (as measured by questionnaire)		Weeks -4 and 32
Secondary	Appetite (as measured by appetite rating scale)		Weeks -4, 0, 16, 32
Secondary	EKG		Weeks -4, 16, 32
Secondary	BNP (brain type natriuretic peptide)		Weeks -4 and 32
Secondary	Energy balance (physical activity recalls, food records, indirect calorimetry)		Weeks -1, 16, 31
Secondary	Compliance (fatty acid composition, pill counts)		Weeks -1, 0, 8, 16, 24, 31, 32
Secondary	Nutrition knowledge		Weeks -4, 0, 32