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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01283113
Recruitment Status : Completed
First Posted : January 25, 2011
Last Update Posted : March 1, 2017
Information provided by (Responsible Party):
Osama Hamdy, 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

Condition or disease
Obesity Type 2 Diabetes Metabolic Syndrome

Study Type : Observational
Actual Enrollment : 110 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Evaluation of Intra-Abdominal Fat Contents in Patients With Type 2 Diabetes Using a Novel Non-Invasive Method of Bioelectric Impedance
Study Start Date : August 2010
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Primary Outcome Measures :
  1. Visceral fat level [ Time Frame: immediate ]

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01283113

United States, Massachusetts
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Joslin Diabetes Center
Principal Investigator: Osama Hamdy, M.D. Joslin Diabetes Center

Responsible Party: Osama Hamdy, Principal Investigator, Joslin Diabetes Center Identifier: NCT01283113     History of Changes
Other Study ID Numbers: CHS # 2010-01
First Posted: January 25, 2011    Key Record Dates
Last Update Posted: March 1, 2017
Last Verified: February 2017

Keywords provided by Osama Hamdy, Joslin Diabetes Center:
Visceral Fat
Waist Circumference
Bioelectrical Impedance
Metabolic Syndrome
Type 2 Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Metabolic Syndrome X
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Resistance