Glucose Uptake in Metabolic Tissues After Bariatric Surgery

NCT03563885 | Terminated

• 1 other identifier: 304180015
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to provide a comprehensive evaluation of whole-body and tissue-specific glucose metabolism after consuming a mixed meal in lean people and people with obesity, before and after 20-35% weight loss induced by Roux-en-Y gastric bypass or sleeve gastrectomy surgery.

Conditions

Obesity; Insulin Resistance

Outcome Measures

Primary Outcomes (1)

• Change in insulin sensitivity

  Insulin sensitivity will be assessed by positron emission topography \& magnetic resonance imaging before and after bariatric surgery

  An average of 6 months from baseline testing to 20-35% weight loss

Study Arms (2)

RYGB or SG

EXPERIMENTAL

Baseline testing followed by subject's already scheduled RYGB or SG surgery, and then post-testing.

Procedure: bariatric surgery

Lean

NO INTERVENTION

Lean control subjects doing baseline testing only.

Interventions

bariatric surgery PROCEDURE

subjects already scheduled Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG) surgery

RYGB or SG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI 35.0-50.0 kg/m2 for obese group and 18.5-24.9 kg/m2 for the lean group
• Must be scheduled for RYGB or SG surgery

You may not qualify if:

• Previous bariatric surgery
• Unstable weight (\>4% change during the last 2 months before entering the study)
• Significant organ system dysfunction (e.g., severe pulmonary or kidney disease)
• Cancer or cancer that has been in remission for \<5 years
• Conditions that render subject unable to complete all testing procedures (e.g. metal implants that interfere with imaging procedures; coagulation disorders)
• Use of medications that are known to affect the study outcome measures or increase the risk of study procedures and that cannot be temporarily discontinued for this study
• Pregnant or lactating women
• Persons who are not able to grant voluntary informed consent
• Persons who are unable or unwilling to follow the study protocol or who, for any reason, the research team considers not an appropriate candidate for this study, including non-compliance with screening appointments or study visits

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Center for Human Nutrition

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Obesity; Insulin Resistance

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Study Officials

• George Schweitzer, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 8, 2018
• First Posted: June 20, 2018
• Study Start: October 1, 2018
• Primary Completion: June 18, 2019
• Study Completion: June 18, 2019
• Last Updated: January 28, 2020

Record last verified: 2020-01

Locations

US (1)