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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Joslin Diabetes Center
Sponsor:
Information provided by (Responsible Party):
Osama Hamdy, Joslin Diabetes Center
ClinicalTrials.gov Identifier:
NCT01283113
First received: January 24, 2011
Last updated: March 25, 2014
Last verified: March 2014

January 24, 2011
March 25, 2014
August 2010
June 2014   (final data collection date for primary outcome measure)
Visceral fat level [ Time Frame: immediate ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT01283113 on ClinicalTrials.gov Archive Site
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Evaluation of Intra-Abdominal Fat in Patients With Type 2 Diabetes Using a Non-Invasive Method
Evaluation of Intra-Abdominal Fat Contents in Patients With Type 2 Diabetes Using a Novel Non-Invasive Method of Bioelectric Impedance

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

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Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
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Non-Probability Sample

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.

  • Obesity
  • Type 2 Diabetes
  • Metabolic Syndrome
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
December 2014
June 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Adham Abdel Mottalib, M.D. (617) 455-8132 adham.mottalib@joslin.harvard.edu
Contact: Osama Hamdy, M.D. (617) 309-2726 osama.hamdy@joslin.harvard.edu
United States
 
NCT01283113
CHS # 2010-01
No
Osama Hamdy, Joslin Diabetes Center
Joslin Diabetes Center
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Principal Investigator: Osama Hamdy, M.D. Joslin Diabetes Center
Joslin Diabetes Center
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP