- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00787670
Impact of GBS on CVD in Type 2 Diabetes Mellitus
Impact of Gastric Bypass Surgery on Risk of CVD in Type 2 Diabetes Mellitus
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27704
- Duke University Health System
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- Clinical diagnosis of T2DM diabetes mellitus with HbA1c ≤ 10.0%
- Current regular use of insulin
- Current regular use of oral hypoglycemic medication.
- 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
- Age between 18-60 years old.
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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gastric bypass surgery to induce weight loss in obese patients with type 2 diabetes
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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
|
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.
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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0, 6, 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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The reduction in CVD risk is mediated by changes in the expression and release of inflammatory-related adipokines by the adipose tissue.
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0, 6, 12 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alfonso Torquati, MD, Duke University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00006703
- 5K23DK075907-02 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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