Impact of GBS on CVD in Type 2 Diabetes Mellitus
|ClinicalTrials.gov Identifier: NCT00787670|
Recruitment Status : Completed
First Posted : November 7, 2008
Last Update Posted : February 5, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Obesity Type 2 Diabetes Mellitus||Other: Diabetes Support and Education Procedure: gastric bypass surgery Other: Tissue Control Group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||84 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Impact of Gastric Bypass Surgery on Risk of CVD in Type 2 Diabetes Mellitus|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||August 2011|
Experimental: Gastric Bypass Surgery
Gastric Bypass Surgery consists of a laparoscopic approach and includes the creation of an isolated 10-15-ml proximal gastric pouch, a retro-colic, retro-gastric Roux-en-Y gastrojejunostomy with linear stapler technique, a 100-cm Roux-limb, a 30-cm biliopancreatic limb, and a stapled end-side enteroenterostomy.
Procedure: gastric bypass surgery
gastric bypass surgery to induce weight loss in obese patients with type 2 diabetes
Active Comparator: Diabetes Support and Education
Diabetes Support and Eduction. Subjects attend three educational/social support sessions for 1 year after enrollment. The educational sessions offered for diabetes support and education including informational sessions on diet/nutrition and exercise. These sessions are informational only and do not teach behavioral self-regulation skills. Different nutrition and exercise topics are covered each session. Education
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.
Active Comparator: Tissue Control Group
Tissue control group includes subjects who are undergoing other non-gastric bypass abdominal surgery. A pea size piece of omentum and subcutaneous fat will be collected.
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.
- To determine whether surgically induced weight loss decreases the risk of CVD in morbidly obese subjects with Type 2 Diabetes Mellitus (T2DM) [ Time Frame: 0, 6, 12 months ]Patients with T2DM who undergo gastric bypass surgery will significantly reduce mean levels of risk factors for CVD compared with diabetic individuals with the same BMI who maintain their weight.
- To elucidate the mechanisms by which surgically induced weight loss reduces over time the risk of CVD in morbidly obese subjects with T2DM. [ Time Frame: 0, 6, 12 months ]The reduction in CVD risk is mediated by changes in the expression and release of inflammatory-related adipokines by the adipose tissue.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00787670
|United States, North Carolina|
|Duke University Health system|
|Durham, North Carolina, United States, 27704|
|Principal Investigator:||Alfonso Torquati, MD||Duke University|