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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01283113
• Other study ID #: CHS # 2010-01
• Status: Completed
• Phase: N/A
• First received: January 24, 2011
• Last updated: February 28, 2017
• Start date: August 2010
• Est. completion date: January 2017

Study information

• Verified date: February 2017
• Source: Joslin Diabetes Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity
• Type 2 Diabetes

Locations

Country	Name	City	State
United States	Joslin Diabetes Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Joslin Diabetes Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visceral fat level		immediate