Clinical trial NCT03705923: Effect of Bariatric Surgery on Brain Insulin Sensitivity
Official title: Metabolic Characterization of Subjects With Adipositas Before and After Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2018-10-15
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Central insulin sensitivity
timeFrame: Central insulin sensitivity will be assessed as change before bariatric surgery and 6 months afterwards.
measure: Peripheral insulin sensitivity
timeFrame: Peripheral insulin sensitivity will be assessed by oral glucose tolerance as change before bariatric surgery and 6 months afterwards.
Secondary outcomes:
measure: Whole body fat distribution
timeFrame: Body fat distribution will be assessed by MRI prior bariatric surgery and 6 months afterwards.
measure: Liver fat content
timeFrame: Liver fat content will be assessed by MRS prior bariatric surgery and 6 months afterwards.
measure: Metabolic rate
timeFrame: Metabolic rate will be assessed by indirect calorimetry prior bariatric surgery and 6 months afterwards.
measure: Response to food cues
timeFrame: Change in response to food cues will be assessed before bariatric surgery and 6 months afterwards.
measure: Trail-making test
timeFrame: Change in trail-making test will be assessed before bariatric surgery and 6 months afterwards.
measure: Hopkins-verbal learning test
timeFrame: Change in Hopkins-verbal learning test will be assessed before bariatric surgery and 6 months afterwards.
measure: Glucose tolerance
timeFrame: Glucose tolerance will be assessed by 75g oral glucose tolerance test prior to bariatric surgery and 6 months afterwards.
measure: Insulin secretion
timeFrame: Insulin secretion will be assessed by insulin measurements during 75g oral glucose tolerance test prior to bariatric surgery and 6 months afterwards.
measure: Weight loss
timeFrame: Weight loss before and 6 months after surgery.
Other outcomes:
measure: Liver, adipose tissue and muscle specimens
timeFrame: At surgery
Locations:
city: Tübingen
country: Germany
facility: University of Tuebingen, Department of Internal Medicine IV
Study officials:
affiliation: University Hospital Tuebingen
name: Martin Heni, MD
role: PRINCIPAL_INVESTIGATOR
References: