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

This study has been completed.
Information provided by (Responsible Party):
Osama Hamdy, Joslin Diabetes Center Identifier:
First received: January 24, 2011
Last updated: February 28, 2017
Last verified: February 2017
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

Obesity Type 2 Diabetes Metabolic Syndrome

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Osama Hamdy, Joslin Diabetes Center:

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

Enrollment: 110
Study Start Date: August 2010
Study Completion Date: January 2017
Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

Responsible Party: Osama Hamdy, Principal Investigator, Joslin Diabetes Center Identifier: NCT01283113     History of Changes
Other Study ID Numbers: CHS # 2010-01
Study First Received: January 24, 2011
Last Updated: February 28, 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
Hyperinsulinism processed this record on September 21, 2017