Effect of Bariatric Surgery on Brain Insulin Sensitivity

NCT ID: NCT03705923

Last Updated: 2022-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2020-12-01

Brief Summary

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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

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Conditions

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Obesity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Bariatric surgery

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

Group Type EXPERIMENTAL

Bariatric surgery

Intervention Type PROCEDURE

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

Interventions

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Bariatric surgery

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martin Heni, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Tuebingen

Locations

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University of Tuebingen, Department of Internal Medicine IV

Tübingen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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714/2017BO1

Identifier Type: -

Identifier Source: org_study_id

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