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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Osama Hamdy, Joslin Diabetes Center
ClinicalTrials.gov Identifier:
NCT01283113
First received: January 24, 2011
Last updated: February 22, 2016
Last verified: February 2016
  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 Joslin Diabetes Center:

Primary Outcome Measures:
  • Visceral fat level [ Time Frame: immediate ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: August 2010
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: January 24, 2011
Last Updated: February 22, 2016
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 26, 2016