Effect of Weight Loss on Brain Insulin Sensitivity in Humans
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|ClinicalTrials.gov Identifier: NCT02991365|
Recruitment Status : Recruiting
First Posted : December 13, 2016
Last Update Posted : July 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Insulin Resistance||Other: nasal insulin Other: placebo spray||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||Effekt Von Gewichtsabnahme Auf Die zentralnervöse Insulinresistenz Des Menschen|
|Actual Study Start Date :||December 2016|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||December 2021|
Active Comparator: nasal insulin
daily administration of 160 U of human insulin as nasal spray
Other: nasal insulin
Placebo Comparator: placebo spray
daily administration of placebo solution as nasal spray
Other: placebo spray
- brain insulin sensitivity [ Time Frame: 30 minutes after administration of nasal insulin ]fMRI measurement will be performed before and after administration of 160 U of human insulin as nasal spray. Changes in regional activity will be quantified to assess regional brain insulin sensitivity.
- Effect of daily administration of 160 U nasal insulin or placebo over 8 weeks on body weight. [ Time Frame: 8 weeks ]Participants will receive nasal insulin or placebo in a double-blind randomized fashion. Before and after 8 weeks body weight will be recorded.
- Effect of daily administration of 160 U nasal insulin or placebo over 8 weeks on glucose tolerance . [ Time Frame: 8 weeks ]Participants will receive nasal insulin or placebo in a double-blind randomized fashion. Before and after 8 weeks glucose tolerance will be assessed using a 75 g oral glucose tolerance test.
- Effect of daily administration of 160 U nasal insulin or placebo over 8 weeks on body composition . [ Time Frame: 8 weeks ]Participants will receive nasal insulin or placebo in a double-blind randomized fashion. Before and after 8 weeks body composition will be addressed by whole-body MRI and liver MRS.
- whole-body insulin sensitivity [ Time Frame: 2 hours ]Insulin sensitivity will be estimated from a frequent-sampling 75 g oral glucose tolerance test using the Matsuda formula.
- Glucose tolerance [ Time Frame: 2 hours ]a 75 g oral glucose tolerance test will be performed. Glucose tolerance will be defined by the American Diabetes Association criteria.
- Cognitive function [ Time Frame: 1 hours ]cognitive function will be addressed by neuropsychological testing.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02991365
|Contact: Andreas Fritsche, MD||+49 7071 29 firstname.lastname@example.org|
|University of Tuebingen, Department of Internal Medicine IV||Recruiting|
|Tübingen, Germany, 72076|
|Contact: Andreas Fritsche, Prof. Dr. +49 7071 29 82714 email@example.com|
|Contact: Martin Heni, Dr. +49 7071 29 82714 firstname.lastname@example.org|
|Sub-Investigator: Martin Heni, MD|
|Principal Investigator:||Andreas Fritsche, MD||University of Tübingen Hospital|