Evaluation of Intra-Abdominal Fat in Patients With Type 2 Diabetes Using a Non-Invasive Method

Completed

• Conditions: Obesity; Metabolic Syndrome; Type 2 Diabetes

• Registration Number: NCT01283113
• Lead Sponsor: Joslin Diabetes Center

Brief Summary

The main aim of this study is to compare 2 different measurements of visceral fat that can be easily used in clinical practice (waist circumference versus bioelectric impedance) in relation to known risk factors of coronary artery disease in a large cohort of patients with type 2 diabetes and with a BMI range between 20-45 kg/m2

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2011-01-24
• Study First Submitted QC: 2011-01-24
• Study First Posted: 2011-01-25
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-28
• Last Update Posted: 2017-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• Established type 2 diabetes
• Age 18 - 80
• Body mass index (BMI) between 20-45 Kg/m2.
• Willing to undergo laboratory and anthropometric assessments.

Exclusion Criteria

• The study will not include women who are pregnant, or are not using reliable birth control methods or who they think that they might be pregnant due to potential risk of fetal affection.
• Subjects with known malignancy, treated or untreated will be excluded (except treated skin melanoma).
• Subjects with major psychological problems or a major eating disorder will be excluded.
• Subjects with heart Pacemaker or any other electronic devices attached to their body will be excluded.
• Subjects with confirmed type 1 diabetes or positive anti GAD antibodies test will be excluded

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visceral fat level	immediate

Trial Locations

Locations (1)

Joslin Diabetes Center; 🇺🇸 Boston, Massachusetts, United States