Zentrale Insulinsensitivität Bei Personen Mit Typ-2-Diabetes Sowie Bei Personen Mit erhöhtem Risiko für Die Entwicklung Von Typ-2-Diabetes

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Beside well described peripheral effects, insulin can also affect the human central nervous system. Centrally acting insulin seems to have an influence e.g. on whole-body metabolism and food intake. Targeting insulin receptors in the central nervous system can modulate peripheral insulin sensitivity as well as pancreatic insulin secretion. In humans, the effect of insulin can be measured in different brain areas as estimate of central nervous insulin sensitivity. Reduced central nervous insulin sensitivity, called central insulin resistance, has been associated, for example, with obesity, unfavorable body fat distribution, and impaired cognitive functionality. Recently novel subtypes and risk clusters of diabetes and prediabetes have been identified. In this study the investigators want to investigate and compare central nervous insulin sensitivity as well as cognitive function in the different diabetes and prediabetes risk clusters.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• manifest diabetes mellitus type 2 with initial diagnosis ≤ 10 years ago, defined as

‣ a fasting blood glucose greater than 126 mg/dl and/or

⁃ a blood glucose greater than 200 mg/dl at the 120 minute time point in the oral glucose tolerance test with 75 g glucose and/or

⁃ an HbA1c greater than 6.5%

• or a currently existing increased risk of developing type 2 diabetes, defined as

‣ prediabetes, defined as

• elevated fasting blood glucose (IFG), fasting blood glucose between 100 and 125 mg/dl) and/or

∙ impaired glucose tolerance (IGT), 120-minute oral glucose tolerance test blood glucose between 140 and 199 mg/dl) and/or

∙ HbA1c between 5.7% and 6.4% with

⁃ and/or at least one of the following factors indicating an increased risk for developing type 2 diabetes mellitus:

• previously existing prediabetes and/or

∙ recent-onset gestational diabetes, and/or

∙ positive family history (1st degree family members) for type 2 diabetes mellitus and/or

∙ BMI greater than 27 kg/m2

• or no manifest diabetes mellitus type 2 and no currently existing increased risk for developing type 2 diabetes (control group: BMI 18.5 to 24.5 kg/m2)

• female and male (1:1), voluntary adults

• at least 18 years old and able to give consent

• understanding of study explanations and instructions

• consent to information in case of unexpected proven pathological findings.

Locations
Other Locations
Germany
University Hospital Tübingen
RECRUITING
Tübingen
Contact Information
Primary
Stephanie Kullmann, Prof.
stephanie.kullmann@med.uni-tuebingen.de
070712987702
Backup
Christian Kübler, Dr.
christian.kuebler@med.uni-tuebingen.de
070712968784
Time Frame
Start Date: 2023-05-26
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 180
Treatments
Active_comparator: Nasal insulin spray
Placebo_comparator: Placebo spray
Related Therapeutic Areas
Sponsors
Leads: University Hospital Tuebingen

This content was sourced from clinicaltrials.gov