Influence of Central Nervous Insulin Sensitivity on Insulin Secretion

Insulin Secretion Clinical Trial

Official title:

Einfluss Der zentralnervösen Insulinsensitivität Auf Die Insulinsekretion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02870361
• Other study ID #: 086/2016BO1
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: April 2018

Study information

• Verified date: May 2018
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Insulin resistance is a central pathophysiological component of type 2 diabetes and is associated with a high risk of cardiovascular disease. The tissue in which it manifests are mainly muscle, liver, and adipose tissue. Since the transport of glucose to the brain is independent of insulin, this organ has traditionally not been studied in this regard. In animal experiments, however, knockout of the insulin receptor in the brain leads to obesity and peripheral insulin resistance. This finding of insulin action in the brain could also be confirmed in human studies.

The investigators intend to investigate whether central nervous insulin action affects insulin secretion in humans. For this purpose, nasal insulin and placebo are administered 15 minutes before a hyperglycemic hyperinsulinemic clamps, which stimulate insulin secretion. Insulin sensitivity of the brain is measured by a an established protocol with functional magnetic resonance imaging before and after nasal insulin administration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• HbA1c =6.0%

• normal glucose tolerance during 75g oral glucose tolerance test (OGTT)

Exclusion Criteria:

• Not removable metal parts in or on the body

• manifest cardiovascular disease

• claustrophobia

• recent surgery (less than 3 months)

• Simultaneous participation in other studies

• Acute disease or infection within the last 4 weeks

• neurological and psychiatric disorders

• treatment with centrally acting drugs

• hemoglobin Hb <13g / dl

• Hypersensitivity to any of the substances used

Related Conditions & MeSH terms

• Insulin Secretion

Intervention

Drug:
• intranasal insulin

• Placebo

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
Primary	Insulin secretion assessed as serum C-peptide levels during a hyperglycemic clamp		0-10 min during hyperglycemic clamp and 10-90 min during hyperglycemic clamp
Secondary	Correlation with brain insulin sensitivity	Correlation of regional brain insulin sensitivity with the change of pancreatic insulin secretion due to central action of insulin. Changes in regional cerebral blood flow from before to after intranasal insulin administration will be assessed by functional magnetresonance imaging (fMRI)	15-30 minutes post insulin nasal spray
Secondary	Differential effects in lean and overweight	Differences in the effect of nasal insulin versus placebo on C-peptide levels during a hyperglycemic clamp between lean and overweight men will be assessed.	0-10 min during hyperglycemic clamp and 10-90 min during hyperglycemic clamp
Secondary	Correlation with autonomous nervous system activity	Correlation of the change in pancreatic insulin secretion by central insulin action with the simultaneous change of the autonomous nervous system (measured by heart rate variability).	10 - 150 minutes post nasal spray
Secondary	Peripheral insulin sensitivity	Effect of nasal insulin versus placebo on peripheral insulin sensitivity assessed by hyperglycemic hyperinsulinemic clamp.	10-90 min and 70-90 min during hyperglycemic clamp