Evaluation of Intra-Abdominal Fat in Patients With Type 2 Diabetes Using a Non-Invasive Method
Verified March 2014 by Joslin Diabetes Center
Information provided by (Responsible Party):
Osama Hamdy, Joslin Diabetes Center
First received: January 24, 2011
Last updated: March 25, 2014
Last verified: March 2014
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
Type 2 Diabetes
||Observational Model: Cohort
Time Perspective: Cross-Sectional
||Evaluation of Intra-Abdominal Fat Contents in Patients With Type 2 Diabetes Using a Novel Non-Invasive Method of Bioelectric Impedance
Primary Outcome Measures:
- Visceral fat level [ Time Frame: immediate ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||June 2014 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years to 80 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
- Established type 2 diabetes
- Age 18 - 80
- Body mass index (BMI) between 20-45 Kg/m2.
- Willing to undergo laboratory and anthropometric assessments.
- 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
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
|Joslin Diabetes Center
|Boston, Massachusetts, United States, 02215 |
|Principal Investigator: Osama Hamdy, M.D. |
Joslin Diabetes Center
||Osama Hamdy, M.D.
||Joslin Diabetes Center
No publications provided
||Osama Hamdy, Principal Investigator, Joslin Diabetes Center
History of Changes
|Other Study ID Numbers:
||CHS # 2010-01
|Study First Received:
||January 24, 2011
||March 25, 2014
||United States: Institutional Review Board
Keywords provided by Joslin Diabetes Center:
Type 2 Diabetes
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 21, 2015
Diabetes Mellitus, Type 2
Metabolic Syndrome X
Endocrine System Diseases
Glucose Metabolism Disorders