The Effect of Leucine on Body Composition and Muscle Characteristics in Elderly, Type 2 Diabetes Patients

Phase 2

Completed

• Conditions: Type 2 Diabetes
• Interventions: Dietary Supplement: Leucine; Dietary Supplement: Wheat flour

• Registration Number: NCT00643773
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

The purpose of this study is to determine whether long term leucine supplementation has a positive effect on body composition and muscle characteristics in elderly, type 2 diabetes patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-03-20
• Study First Submitted QC: 2008-03-25
• Study First Posted: 2008-03-26
• Study Start: 2008-05
• Primary Completion: 2009-12
• Study Completion: 2010-06
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-25
• Last Update Posted: 2011-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

• Clinical diagnosis of type 2 diabetes

Exclusion Criteria

• Impaired renal or liver function
• Cardiac disease
• Subjects with metal implants
• Hypertension
• Diabetes complications
• Exogenous insulin therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
A	Leucine	Leucine supplement
B	Wheat flour	Wheat flour

Primary Outcome Measures

Name	Time	Method
Body Composition	1, 3, and 6 months

Secondary Outcome Measures

Name	Time	Method
Muscle characteristics	1, 3, and 6 months

Trial Locations

Locations (1)

Maastricht University; 🇳🇱 Maastricht, Netherlands