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

NCT01283113 | Completed

• 1 other identifier: CHS # 2010-01
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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

Conditions

Obesity; Type 2 Diabetes; Metabolic Syndrome

Keywords

Visceral Fat; Waist Circumference; Bioelectrical Impedance; Metabolic Syndrome; Obesity; Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Visceral fat level

  immediate

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The investigators will identify and recruit 500 patients. Participants for this study (men and women) will be recruited for the diabetes outpatient clinic of the Joslin Diabetes Center. Subjects from minority and various ethnic/racial groups will be invited to participate in the study at the same proportional to Massachusetts's population, which is 86.5% white, 6.9 Black, 0.3% American Indian and Alaska, 4.9 Asian, 0.1% Native Hawaiian and Other Pacific Islander and 8.2% of Hispanic or Latino origin. The investigators will monitor our recruitment by gender and race/ethnicity and modify our recruitment procedures if necessary to ensure that there is no selection bias due to these factors.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Joslin Diabetes Center: lead

Study Sites (1)

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Insulin Resistance; Hyperinsulinism

Study Officials

• Osama Hamdy, M.D.

  Joslin Diabetes Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 24, 2011
• First Posted: January 25, 2011
• Study Start: August 1, 2010
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: April 23, 2026

Record last verified: 2017-02

Locations

US (1)