Effect of Bariatric Surgery on Brain Insulin Sensitivity

Not Applicable

Terminated

• Conditions: Obesity
• Interventions: Procedure: Bariatric surgery

• Registration Number: NCT03705923
• Lead Sponsor: University Hospital Tuebingen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-09
• Study First Submitted QC: 2018-10-10
• Study First Posted: 2018-10-15
• Study Start: 2018-12-01
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-01
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-14
• Last Update Posted: 2022-01-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bariatric surgery	Bariatric surgery	Subjects undergoing laparoscopic Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy.

Primary Outcome Measures

Name	Time	Method
Central insulin sensitivity	Central insulin sensitivity will be assessed as change before bariatric surgery and 6 months afterwards.	Central insulin sensitivity will be assessed by fMRI after application of nasal insulin or placebo.
Peripheral insulin sensitivity	Peripheral insulin sensitivity will be assessed by oral glucose tolerance as change before bariatric surgery and 6 months afterwards.	Peripheral insulin sensitivity will be assessed by oral glucose tolerance test.

Secondary Outcome Measures

Name	Time	Method
Whole body fat distribution	Body fat distribution will be assessed by MRI prior bariatric surgery and 6 months afterwards.	Body fat distribution will be assessed by MRI
Liver fat content	Liver fat content will be assessed by MRS prior bariatric surgery and 6 months afterwards.	Liver fat content will be assessed by MRS
Response to food cues	Change in response to food cues will be assessed before bariatric surgery and 6 months afterwards.	Food cues will be rated for palatability on a visual analogue scale
Trail-making test	Change in trail-making test will be assessed before bariatric surgery and 6 months afterwards.	Trail-making test will be performed
Glucose tolerance	Glucose tolerance will be assessed by 75g oral glucose tolerance test prior to bariatric surgery and 6 months afterwards.	Glucose tolerance will be assessed by 75g oral glucose tolerance test.
Weight loss	Weight loss before and 6 months after surgery.	Body weight will be measured before and 6 months after surgery.
Metabolic rate	Metabolic rate will be assessed by indirect calorimetry prior bariatric surgery and 6 months afterwards.	Metabolic rate will be assessed by indirect calorimetry
Hopkins-verbal learning test	Change in Hopkins-verbal learning test will be assessed before bariatric surgery and 6 months afterwards.	Hopkins-verbal learning test will be performed
Insulin secretion	Insulin secretion will be assessed by insulin measurements during 75g oral glucose tolerance test prior to bariatric surgery and 6 months afterwards.	Insulin secretion will be assessed by insulin measurements during 75g oral glucose tolerance test.

Trial Locations

Locations (1)

University of Tuebingen, Department of Internal Medicine IV; 🇩🇪 Tübingen, Germany