Impact of GBS on CVD in Type 2 Diabetes Mellitus - Full Text View

Sponsor:	Duke University
Information provided by:	Duke University
ClinicalTrials.gov Identifier:	NCT00787670

Purpose

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 echodoppler, 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	Intervention
Obesity Type 2 Diabetes Mellitus	Dietary Supplement: non-surgery Control Procedure: gastric bypass surgery Other: tissure control group

Study Type:	Interventional
Study Design:	Basic Science, Non-Randomized, Open Label, Active Control, Parallel Assignment
Official Title:	Impact of Gastric Bypass Surgery on Risk of CVD in Type 2 Diabetes Mellitus

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diets Obesity Surgery Weight Control

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:

Carotid artery intima-media thickness [ Time Frame: 0, 6, 12 months ] [ Designated as safety issue: No ]
Brachial artery flow mediated dilation [ Time Frame: 0, 6, 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Insulin Sensitivity [ Time Frame: 0, 6, 12 months ] [ Designated as safety issue: No ]
Body Composition [ Time Frame: 0, 6, 12 months ] [ Designated as safety issue: No ]
Lipoprotein Profile [ Time Frame: 0, 6, 12 months ] [ Designated as safety issue: No ]
Inflammatory Markers [ Time Frame: 0, 6, 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	90
Study Start Date:	November 2008
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental surgery group	Procedure: gastric bypass surgery gastric bypass surgery to induce weight loss in obese patients with type 2 diabetes
2: Active Comparator Non-surgery group.	Dietary Supplement: non-surgery Control Calorie controlled diabetic diet for control group in comparison with gastric bypass surgery to induce weight loss in obese patients with type 2 diabetes
3: Active Comparator Tissue control group	Other: tissure 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.

Detailed Description:

Patients with type 2 diabetes mellitus (T2DM) are more likely to die from cardiovascular diseases (CVD) than people without diabetes. Furthermore, Patients with diabetes have not benefited from the advances in the management of CVD and/or its risk factors that have resulted in a decrease in mortality for CVD patients without diabetes. Short-term studies have demonstrated that weight loss in over weight or obese subjects with T2DM is associated with decreased insulin resistance, substantial improvements in glycemic and lipoprotein profile, and reduction in blood pressure. However, Long-term data substantiating that these improvements can be maintained are limited. Obesity, and susceptibility to weight gain, is a chronic condition. Continuous care is required to avoid weight regain especially after intensive weigh loss. Morbidly obese patients with body mass index (BMI) over 35 kg/m2 have significant difficulties maintaining weight loss adequate to resolve obesity-related medical conditions by changes in lifestyle or pharmacologic strategies. Currently, surgical treatment of morbid obesity, termed bariatric surgery, appears to be the only modality that results in significant and sustained weight loss along with reversal of diabetes and improvements in cholesterol biosynthesis, and lipoprotein metabolism in morbidly obese patients. Given these observations, we question if patients with T2DM who undergo gastric bypass surgery will significantly reduce levels of abnormalities in vascular structure and function that are central to the development of atherosclerosis. In specific aim 1, we will determine whether surgically induced weight loss decreases the risk of CVD in morbidly obese subjects with T2DM. . In specific aim 2, we will elucidate the mechanisms by which surgically induced weight loss reduces over time the risk of CVD in morbidly obsess subjects with T2DM. The proposed study is a prospective cohort clinic trial aimed to evaluate changes over time in cardiovascular structure and function of morbidly obese subjects with T2DM undergoing gastric bypass surgery compared to a matched control group who do not undergo gastric bypass surgery. The results of the proposed study will provide the foundation for a new clinic strategy aimed to prevent the development of CVD in obese patients with T2DM. Furthermore, it will serve as the baseline for future large scale longitudinal studies based on aggregate occurrence of severe cardiovascular events.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria

Clinical diagnosis of T2DM diabetes mellitus with HbA1c ≤ 10.0%

Any one of the following will be considered to be sufficient evidence that diabetes is present:
1. Current regular use of insulin
2. Current regular use of oral hypoglycemic medication.
3. Documented diabetes by current ADA criteria (98).
Body mass index ≥ 35 kg/m2 in accord with the 1991 NIH obesity surgery consensus conference criteria and stable weight for the previous 3 months (99).
Age between 18-60 years old. Individuals older than 60 years of age are excluded due to their increased risk of mortality and peri-operative morbidity.
Ability and willingness to provide informed consent.
No expectation that subject will be moving out of the area of the clinical center during the next 12 months.

Exclusion criteria

Presence of CVD defined as: CAD, electrocardiographic criteria for past myocardial infarction(s), ischemic stroke, peripheral artery bypass surgery, percutaneous transluminal angioplasty, or amputation because of atherosclerotic disease.
Significant non-diabetic co-morbidity affecting life expectancy (e.g., malignancy).
Significant other co-morbidities (e.g. psychiatric disorder) that results in ineligibility for gastric bypass surgery.
Pregnancy or planning pregnancy.
Severe dyslipidemia (triglycerides >600 mg/dl or cholesterol >350 mg/dl).
Uncontrolled hypertension.
Smoking.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00787670

Contacts

Contact: Alfonso Torquati, MD.	919-470-7040	alfonso.torquati@duke.edu
Contact: Ning Jiang, MD	919-479-2363	ning.jiang@duke.edu

Locations

United States, North Carolina
Duke University Health system	Recruiting
Durham, North Carolina, United States, 27704
Contact: alfonso Torquati, MD 919-470-7040 alfonso.torquati@duke.edu
Contact: Ning Jiang, MD 919-479-2363 ning.jiang@duke.edu
Principal Investigator: Alfonso Torquati, MD

Sponsors and Collaborators

Duke University

Investigators

Principal Investigator:

Alfonso Torquati, MD

Duke University

More Information

No publications provided

Responsible Party:	Duke University ( Dr. Alfonso Torquati, Associate Professor )
Study ID Numbers:	Pro00006703, 5K23DK075907-02
Study First Received:	November 6, 2008
Last Updated:	September 30, 2009
ClinicalTrials.gov Identifier:	NCT00787670 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Duke University:

Obese
Type 2 Diabetes Mellitus
Gastric Bypass surgery
Risk of cardiovascular diseases

Additional relevant MeSH terms:

Diabetes Mellitus, Type 2
Body Weight
Signs and Symptoms
Obesity
Metabolic Diseases
Diabetes Mellitus

Nutrition Disorders
Endocrine System Diseases
Overweight
Overnutrition
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010