Effect of Bariatric Surgery on Brain Insulin Sensitivity

Obesity Clinical Trial

Official title:

Metabolic Characterization of Subjects With Adipositas Before and After Bariatric Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03705923
• Other study ID #: 714/2017BO1
• Status: Terminated
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: December 1, 2020

Study information

• Verified date: December 2021
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Procedure:
• Bariatric surgery
laparoscopic Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy

Locations

Country	Name	City	State
Germany	University of Tuebingen, Department of Internal Medicine IV	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Liver, adipose tissue and muscle specimens	During surgery liver, subcutaneous and visceral adipose tissue and skeletal muscle will be collected.	At surgery
Primary	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.
Primary	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	Whole body fat distribution	Body fat distribution will be assessed by MRI	Body fat distribution will be assessed by MRI prior bariatric surgery and 6 months afterwards.
Secondary	Liver fat content	Liver fat content will be assessed by MRS	Liver fat content will be assessed by MRS prior bariatric surgery and 6 months afterwards.
Secondary	Metabolic rate	Metabolic rate will be assessed by indirect calorimetry	Metabolic rate will be assessed by indirect calorimetry prior bariatric surgery and 6 months afterwards.
Secondary	Response to food cues	Food cues will be rated for palatability on a visual analogue scale	Change in response to food cues will be assessed before bariatric surgery and 6 months afterwards.
Secondary	Trail-making test	Trail-making test will be performed	Change in trail-making test will be assessed before bariatric surgery and 6 months afterwards.
Secondary	Hopkins-verbal learning test	Hopkins-verbal learning test will be performed	Change in Hopkins-verbal learning test will be assessed before bariatric surgery and 6 months afterwards.
Secondary	Glucose tolerance	Glucose tolerance will be assessed by 75g oral glucose tolerance test.	Glucose tolerance will be assessed by 75g oral glucose tolerance test prior to bariatric surgery and 6 months afterwards.
Secondary	Insulin secretion	Insulin secretion will be assessed by insulin measurements during 75g oral glucose tolerance test.	Insulin secretion will be assessed by insulin measurements during 75g oral glucose tolerance test prior to bariatric surgery and 6 months afterwards.
Secondary	Weight loss	Body weight will be measured before and 6 months after surgery.	Weight loss before and 6 months after surgery.