NCT05856877 Central Insulin Sensitivity in Individuals With Type 2 Diabetes (T2D) and at Risk for Developing T2D
| NCT ID | NCT05856877 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital Tuebingen |
| Condition | Central Insulin Resistance |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2023-05-26 |
| Primary Completion | 2025-05-31 |
Trial Parameters
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Brief 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 Criteria
Inclusion Criteria: 1. 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% 2. 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