NCT00787670

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Nov 2008

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

November 6, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 7, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

February 5, 2013

Status Verified

February 1, 2013

Enrollment Period

2.7 years

First QC Date

November 6, 2008

Last Update Submit

February 4, 2013

Conditions

ObesityType 2 Diabetes Mellitus

Keywords

ObeseType 2 Diabetes MellitusGastric Bypass surgeryRisk of cardiovascular diseases

Outcome Measures

Primary Outcomes (1)

  • To determine whether surgically induced weight loss decreases the risk of CVD in morbidly obese subjects with Type 2 Diabetes Mellitus (T2DM)

    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.

    0, 6, 12 months

Secondary Outcomes (1)

  • To elucidate the mechanisms by which surgically induced weight loss reduces over time the risk of CVD in morbidly obese subjects with T2DM.

    0, 6, 12 months

Study Arms (3)

Gastric Bypass Surgery

EXPERIMENTAL

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

Diabetes Support and Education

ACTIVE COMPARATOR

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

Tissue Control Group

ACTIVE COMPARATOR

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

Interventions

Diabetes Support and EducationOTHER

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.

Diabetes Support and Education
gastric bypass surgeryPROCEDURE

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

Gastric Bypass Surgery
Tissue Control GroupOTHER

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.

Tissue Control Group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Health system

Durham, North Carolina, 27704, United States

Location

Related Publications (1)

  • Khoo CM, Chen J, Pamuklar Z, Torquati A. Effects of Roux-en-Y gastric bypass or diabetes support and education on insulin sensitivity and insulin secretion in morbidly obese patients with type 2 diabetes. Ann Surg. 2014 Mar;259(3):494-501. doi: 10.1097/SLA.0b013e318294d19c.

    PMID: 23732262DERIVED

MeSH Terms

Conditions

ObesityDiabetes Mellitus, Type 2

Interventions

Educational Status

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Alfonso Torquati, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2008

First Posted

November 7, 2008

Study Start

November 1, 2008

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

February 5, 2013

Record last verified: 2013-02

Locations

US(1)