Evaluation of Intra-Abdominal Fat Contents in Patients With Type 2 Diabetes Using a Novel Non-Invasive Method of Bioelectric Impedance
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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 |
- Visceral fat level [ Time Frame: immediate ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 500 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | June 2013 (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 |
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| 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, Massachusetts | |
| Joslin Diabetes Center | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Principal Investigator: Osama Hamdy, M.D. | |
| Principal Investigator: | Osama Hamdy, M.D. | Joslin Diabetes Center |
More Information
No publications provided
| 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: | May 22, 2013 |
| 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 Diabetes Mellitus, Type 2 Obesity Metabolic Syndrome X Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Insulin Resistance Hyperinsulinism |
ClinicalTrials.gov processed this record on May 23, 2013