MedTrace Logo

Impact of GBS on CVD in Type 2 Diabetes Mellitus

NCT00787670 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2013-02-05

No results posted yet for this study

Summary

This research is a NIH single site study with the aims to (1) determine whether surgically induced weight loss decreases the risk of CVD in morbidly obese subjects with T2DM. (2) elucidate the mechanisms by which surgically induced weight loss reduces over time the risk of CVD in morbidly obsess subjects with T2DM.

Study'subjects will be enrolled from obese individuals with type 2 diabetes (T2DM). The study includes two groups, subjects undergoing gastric bypass surgery and a control group not undergoing weight loss surgery. A total of 60 subjects (30 in each group) will be recruited.

Basal, 6 and 12 months assessments will include: insulin sensitivity determination, cardiovascular function by echo doppler, and DEXA scan.

This study involves risk-level II procedures, however, the risks inherent to the gastric bypass surgery are not considered study-derived because subjects are enrolled from individuals that have already decided to have this surgery. We will determine protein expression profiles of inflammation-related adipokines in the subcutaneous and intra-abdominal adipose tissues of morbidly obese subjects with T2DM before and after surgically induced weight loss.

Conditions

Interventions

OTHER

Diabetes Support and Education

The subjects will attend three educational/social support sessions for 1 year after enrollment. The educational sessions include informational sessions on diet/nutrition and exercise. These sessions are informational and do not teach behavioral self-regulation skills.

PROCEDURE

gastric bypass surgery

gastric bypass surgery to induce weight loss in obese patients with type 2 diabetes

OTHER

Tissue Control Group

During the abdominal surgery we would like to take 5 ml blood from the IV line and small pea-sized samples of the fat tissue just under the skin and around the stomach area. These samples will be stored so that we can compare these tissue with other patients.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Duke University

    lead OTHER

Principal Investigators

  • Alfonso Torquati, MD · Duke University

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00787670 on ClinicalTrials.gov