Effect of Bariatric Surgery on Brain Insulin Sensitivity

NCT03705923 | Terminated

• 1 other identifier: 714/2017BO1
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Adiposity is associated with prediabetes and type 2 diabetes. In very severe cases of adiposity in combination with type 2 diabetes, bariatric surgery has proven to be a successful therapy option. So far the molecular mechanisms that lead to an improvement of type 2 diabetes after bariatric surgery are not fully understood. It is planned to characterize the metabolic and neuroendocrine changes in subjects before and after bariatric surgery. One special focus of the study is brain insulin resistance, a condition known to be associated with obesity with impact on the brain and whole body metabolism.

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

• Central insulin sensitivity

  Central insulin sensitivity will be assessed by fMRI after application of nasal insulin or placebo.

  Central insulin sensitivity will be assessed as change before bariatric surgery and 6 months afterwards.

• Peripheral insulin sensitivity

  Peripheral insulin sensitivity will be assessed by oral glucose tolerance test.

  Peripheral insulin sensitivity will be assessed by oral glucose tolerance as change before bariatric surgery and 6 months afterwards.

Secondary Outcomes (9)

• Whole body fat distribution

  Body fat distribution will be assessed by MRI prior bariatric surgery and 6 months afterwards.

• Liver fat content

  Liver fat content will be assessed by MRS prior bariatric surgery and 6 months afterwards.

• Metabolic rate

  Metabolic rate will be assessed by indirect calorimetry prior bariatric surgery and 6 months afterwards.

• Response to food cues

  Change in response to food cues will be assessed before bariatric surgery and 6 months afterwards.

• Trail-making test

  Change in trail-making test will be assessed before bariatric surgery and 6 months afterwards.

Other Outcomes (1)

• Liver, adipose tissue and muscle specimens

  At surgery

Study Arms (1)

Bariatric surgery

EXPERIMENTAL

Subjects undergoing laparoscopic Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy.

Procedure: Bariatric surgery

Interventions

Bariatric surgery PROCEDURE

laparoscopic Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy

Bariatric surgery

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age between 18 and 75 years
• planned bariatric surgery (laparoscopic Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy)
• stable medication 10 weeks before begin of the study

You may not qualify if:

• persons who wear non-removable metal parts in or on the body.
• persons with reduced temperature sensitivity and / or increased sensitivity to heating of the body
• cardiovascular disease can not be ruled out, e.g. manifest coronary heart disease, heart failure greater than NYHA 2, previous heart attack, stroke condition
• persons with hearing impairment or increased sensitivity to loud noises
• people with claustrophobia
• minors or non-consenting subjects are also excluded
• subjects with an operation less than 3 months
• neurological and psychiatric disorders
• subjects with hemoglobin Hb \<11 g / dl
• hypersensitivity to any of the substances used

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University of Tuebingen, Department of Internal Medicine IV

Tübingen, 72076, Germany

Location

MeSH Terms

Conditions

Obesity

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Study Officials

• Martin Heni, MD

  University Hospital Tuebingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2018
• First Posted: October 15, 2018
• Study Start: December 1, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: January 5, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)