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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
Sponsor:
Information provided by (Responsible Party):
University Hospital Tuebingen

Brief Summary:
Obesity if known to be associated with brain insulin resistance in humans. This condition has not only implication for the brain but also for whole-body energy homeostasis. Research in rodents indicates that weight loss is able to improve insulin sensitivity of the brain. The current project will test this hypothesis in humans. Therefore, brain insulin sensitivity will be assessed by fMRI in combination with intranasal insulin administration, using an established protocol. Furthermore, effects of daily administration of insulin nasal spray (versus placebo) over 8 weeks will be assessed as secondary (exploratory) variables.

Condition or disease Intervention/treatment Phase
Insulin Resistance Other: nasal insulin Other: placebo spray Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Cognitive function [ Time Frame: 1 hours ]
    cognitive function will be addressed by neuropsychological testing.



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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • HbA1c <6.5%
  • Age between 40 and 75 years
  • No intake of antidiabetic drugs or drugs for weight reduction
  • no steroid intake
  • Stable medication over 10 weeks before the start 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
  • Simultaneous participation in other studies
  • Neurological and psychiatric disorders
  • Subjects with hemoglobin Hb <11 g / dl
  • Hypersensitivity to any of the substances used

Information from the National Library of Medicine

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


Contacts
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Contact: Andreas Fritsche, MD +49 7071 29 80687 andreas.fritsche@med.uni-tuebingen.de

Locations
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Germany
University of Tuebingen, Department of Internal Medicine IV Recruiting
Tübingen, Germany, 72076
Contact: Andreas Fritsche, Prof. Dr.    +49 7071 29 82714    andreas.fritsche@med.uni-tuebingen.de   
Contact: Martin Heni, Dr.    +49 7071 29 82714    martin.heni@med.uni-tuebingen.de   
Sub-Investigator: Martin Heni, MD         
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
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Principal Investigator: Andreas Fritsche, MD University of Tübingen Hospital
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Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT02991365    
Other Study ID Numbers: 8 weeks study
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: July 21, 2020
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs