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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01283113
First Posted: January 25, 2011
Last Update Posted: March 1, 2017
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.
Information provided by (Responsible Party):
Osama Hamdy, Joslin Diabetes Center
  Purpose
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
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)
  Eligibility

Information from the National Library of Medicine

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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.
Criteria

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
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 ClinicalTrials.gov identifier (NCT number): NCT01283113


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

Responsible Party: Osama Hamdy, Principal Investigator, Joslin Diabetes Center
ClinicalTrials.gov Identifier: NCT01283113     History of Changes
Other Study ID Numbers: CHS # 2010-01
First Submitted: January 24, 2011
First Posted: January 25, 2011
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
Obesity
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