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"Effect of Central Insulin Administration on Whole-body Insulin Sensitivity in Women"

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ClinicalTrials.gov Identifier: NCT03929419
Recruitment Status : Recruiting
First Posted : April 26, 2019
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital Tuebingen

Brief Summary:

The human brain is an insulin sensitive organ. Brain insulin action modulates peripheral insulin sensitivity in young lean men. As a underlying mechanism, the investigators previously detected suppression of endogenous glucose production and stimulation of glucose disappearance to peripheral tissue in response to brain insulin delivery by nasal spray. Whether this holds true in young woman is unknown, since differences in brain insulin response between sexes have been reported. The investigators will address this question by combining the delivery of insulin to the brain as nasal spray with hyperinsulinemic euglycemic clamp experiments in natural cycling women.

In the planned randomized, placebo controlled cross-over study, female participants will undergo four hyperinsulinemic euglycemic experiments with tracer dilution, two in the first phase and two in the second phase of their menstrual cycle. On one of the study days per menstrual phase, subjects will receive intranasal insulin administration, on the other placebo spray. The protocol has been successfully applied previously in men. Based on the results of this trial, the investigators calculated a required sample size of N=10 for the planned study in women.

These experiments will help to better understand the role of brain insulin action in a broader sense. The results can be the basis for larger clinical trials that address the sex-specific impact of brain insulin resistance for glucose metabolism and diabetes risk.


Condition or disease Intervention/treatment Phase
Insulin Sensitivity Drug: intranasal insulin Drug: Placebo spray Not Applicable

Detailed Description:

"Effect of central insulin administration on whole-body insulin sensitivity in women" The human brain is an insulin sensitive organ. Brain insulin action modulates peripheral insulin sensitivity in young lean men. As a underlying mechanism, the investigators previously detected suppression of endogenous glucose production and stimulation of glucose disappearance to peripheral tissue in response to brain insulin delivery by nasal spray. Whether this holds true in young woman is unknown, since differences in brain insulin response between sexes have been reported. The investigators will address this question by combining the delivery of insulin to the brain as nasal spray with hyperinsulinemic euglycemic clamp experiments in natural cycling women.

In the planned randomized, placebo controlled cross-over study, female participants will undergo four hyperinsulinemic euglycemic experiments with tracer dilution, two in the first phase and two in the second phase of their menstrual cycle. On one of the study days per menstrual phase, subjects will receive intranasal insulin administration, on the other placebo spray. The protocol has been successfully applied previously in men. Based on the results of this trial, the investigators calculated a required sample size of N=10 for the planned study in women.

These experiments will help to better understand the role of brain insulin action in a broader sense. The results can be the basis for larger clinical trials that address the sex-specific impact of brain insulin resistance for glucose metabolism and diabetes risk.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: "Effect of Central Insulin Administration on Whole-body Insulin Sensitivity in Women"
Estimated Study Start Date : April 21, 2019
Estimated Primary Completion Date : April 21, 2020
Estimated Study Completion Date : April 21, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Active Comparator: Insulin nasal spray
160 Units of human insulin as nasal spray
Drug: intranasal insulin
application of 160 units human insulin

Placebo Comparator: Placebo nasal spray
Nasal spray containing placebo solution
Drug: Placebo spray
nasal spray containing placebo solution




Primary Outcome Measures :
  1. Change in the peripheral insulin sensitivity [ Time Frame: 60-90 minutes and 150-210 minutes during euglycemic clamp ]
    Effect of nasal insulin versus placebo on peripheral insulin sensitivity assessed by euglycemic hyperinsulinemic clamp.


Secondary Outcome Measures :
  1. Correlation with autonomous nervous system activity [ Time Frame: 70-80 minutes and 190-200 minutes during euglycemic clamp ]
    Correlation of the change in peripheral insulin sensitivity by central insulin action with the simultaneous change of the autonomous nervous system (measured by heart rate variability).

  2. Differential effects dependent on female sexual hormones [ Time Frame: 60-90 minutes and 150-210 minutes during euglycemic clamp ]
    Correlation of the change in peripheral insulin sensitivity by central insulin action dependent on the time point in menstrual cycle

  3. Effect of menstrual cycle on insulin sensitivity before spray application [ Time Frame: 60-90minutes ]
    Will be measured by hyperinsulinemic euglycemic clamp



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • female volunteer adults
  • HbA1c <6.0%
  • Age between 18 and 30 years
  • Standard routine laboratory
  • No underlying diseases
  • No medication
  • No hormonal contraception
  • Understanding of the explanations of the study and the instructions

Exclusion Criteria:

  • Persons with limited temperature perception and / or increased temperature Sensitivity to warming of the body
  • Cardiovascular disease, such as manifest coronary Heart disease, heart failure greater than NYHA 2, recent myocardial infarction
  • People with a hearing disorder or increased sensitivity to loud Sounds
  • persons with claustrophobia
  • Minors or non-consenting subjects are also excluded
  • Pregnancy or breastfeeding women
  • Surgery less than 3 months ago
  • Simultaneous participation in other interventional studies
  • Acute illness or infection within the last 4 weeks
  • Neurological and psychiatric disorders
  • Subjects with hemoglobin Hb <12g / dl (at screening)
  • Allergic diseases
  • Individuals with a history of heparin-induced thrombocytopenia (HIT)

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): NCT03929419


Contacts
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Contact: Martin Heni 0049 7071 2982711 martin.heni@med.uni-tuebingen.de

Locations
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Germany
University of Tuebingen, Department of Internal Medicine IV Recruiting
Tuebingen, Germany, 72076
Contact: Martin Heni, MD    +49 7071 29 82714    martin.heni@med.uni-tuebingen.de   
Contact: Andreas Fritsche, MD    +49 7071 29 82714    andreas.fritsche@med.uni-tuebingen.de   
Sponsors and Collaborators
University Hospital Tuebingen

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Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT03929419     History of Changes
Other Study ID Numbers: 568/2018BO1
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Insulin Resistance
Hypersensitivity
Immune System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs