Bariatric Surgery And Adipose Inflammation Dysfunction and Type 2 Diabetes Mellitus

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
Collaborator:
American Diabetes Association
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01882036
First received: June 21, 2012
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

The focus of this proposal is to define the mechanism by which bariatric surgery acutely improves glucose homeostasis. Our central hypothesis is that drastically reduced caloric intake early after Roux-en-Y Gastric Bypass (RYGB) improves the pro-inflammatory profile of macrophages, which in turn improves insulin sensitivity and glucose homeostasis.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Insulin Resistance
Procedure: Roux en Y Gastric Bypass
Other: Hypocaloric diet
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effects of Roux-en-Y Gastric Bypass on Mitochondrial Dysfunction and Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Measure homeostasis model assessment i.e. estimated change in insulin resistance (HOMA-IR) index [ Time Frame: Seven days before and 10 days following RYGB or hypocaloric diet similar to RYGB patients ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: November 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: RYGB with matched hypocaloric diet Procedure: Roux en Y Gastric Bypass
Roux en Y Gastric Bypass with Hypocaloric liquid diet for 10 days
Active Comparator: Hypocaloric Diet Other: Hypocaloric diet
Hypocaloric liquid diet for 10 days

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria::

  1. Candidate for RYGB gastric bypass with insurance approval.
  2. Willing to accept randomization to either immediate surgery, or delayed surgery after diet study.
  3. Willing to undergo two sessions of testing before, and ten days after surgery (or initiation of dietary intervention).
  4. BMI 35-45kg/m2
  5. Pre-diabetes (ADA criteria) or T2DM with HbA1c< 8%.

Exclusion criteria:

  1. T1DM.
  2. Serious illness such as cancer, active chronic infection, cardiovascular disease greater that New York Heart Association class 2, chronic renal failure, chronic lung disease.
  3. Inflammatory or celiac intestinal disease.
  4. Untreated thyroid disease.
  5. Serious psychiatric disease.
  6. Excessive alcohol use.
  7. Illicit drug use. -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01882036

Contacts
Contact: JOYCE L SCHONE, RD 612-273-4860 jschone1@fairview.org
Contact: Stanley E E. Williams, PhD 612 6253265 willi004@umn.edu

Locations
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Joyce L Schone, RD    612-273-4860    jschone1@fairview.org   
Contact: Stanley E E. Williams, PhD    612 6253265    willi004@umn.edu   
Principal Investigator: Sayeed Ikramuddin, MD         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
American Diabetes Association
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01882036     History of Changes
Other Study ID Numbers: 0908M70742
Study First Received: June 21, 2012
Last Updated: June 17, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism

ClinicalTrials.gov processed this record on July 23, 2014