Bariatric Surgery And Adipose Inflammation Dysfunction and Type 2 Diabetes Mellitus
The Effects of Roux-en-Y Gastric Bypass on Mitochondrial Dysfunction and Type 2 Diabetes Mellitus
1 other identifier
interventional
57
1 country
1
Brief Summary
The focus of this proposal is to define the mechanism by which bariatric surgery acutely improves insulin sensitivity. Our central hypothesis is that drastically reduced caloric intake early after Bariatric surgery improves the pro-inflammatory profile of macrophages, which in turn improves insulin sensitivity and glucose homeostasis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable type-2-diabetes-mellitus
Started Nov 2011
Longer than P75 for not_applicable type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 21, 2012
CompletedFirst Posted
Study publicly available on registry
June 20, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 10, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 10, 2018
CompletedFebruary 14, 2023
February 1, 2023
6.7 years
June 21, 2012
February 10, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Measure homeostasis model assessment i.e. estimated change in insulin resistance (HOMA-IR) index
Seven days before and 10 days following RYGB or hypocaloric diet similar to RYGB patients
Study Arms (2)
Gastric Bypass w/ matched hypocaloric diet
ACTIVE COMPARATORHypocaloric Diet
ACTIVE COMPARATORInterventions
Roux en Y Gastric Bypass with Hypocaloric liquid diet for 10 days
Eligibility Criteria
You may qualify if:
- Candidate for RYGB gastric bypass with insurance approval.
- Willing to accept randomization to either immediate surgery, or delayed surgery after diet study.
- Willing to undergo two sessions of testing before, and ten days after surgery (or initiation of dietary intervention).
- BMI 35-45kg/m2
- Pre-diabetes (ADA criteria) or T2DM with HbA1c\< 8%.
You may not qualify if:
- T1DM.
- Serious illness such as cancer, active chronic infection, cardiovascular disease greater that New York Heart Association class 2, chronic renal failure, chronic lung disease.
- Inflammatory or celiac intestinal disease.
- Untreated thyroid disease.
- Serious psychiatric disease.
- Excessive alcohol use.
- Illicit drug use. -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Minnesotalead
- American Diabetes Associationcollaborator
Study Sites (1)
University of Minnesota
Minneapolis, Minnesota, 55455, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sayeed Ikramuddin, MD
University of Minnesota
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2012
First Posted
June 20, 2013
Study Start
November 1, 2011
Primary Completion
July 10, 2018
Study Completion
July 10, 2018
Last Updated
February 14, 2023
Record last verified: 2023-02