Actively Recruiting
Central Insulin Sensitivity in Individuals With Type 2 Diabetes (T2D) and at Risk for Developing T2D
Led by University Hospital Tuebingen · Updated on 2024-05-14
180
Participants Needed
1
Research Sites
135 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Central Insulin Sensitivity in Individuals With Type 2 Diabetes (T2D) and at Risk for Developing T2D
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older and able to give consent
- Adults with type 2 diabetes diagnosed within the last 10 years, defined by fasting blood glucose >126 mg/dl, or glucose >200 mg/dl after 120 minutes in oral glucose tolerance test, or HbA1c >6.5%
- Adults with increased risk of developing type 2 diabetes, including prediabetes (impaired fasting glucose 100-125 mg/dl, impaired glucose tolerance 140-199 mg/dl, or HbA1c 5.7%-6.4%)
- Presence of at least one risk factor for type 2 diabetes such as previous prediabetes, recent gestational diabetes, family history of type 2 diabetes, or BMI over 27 kg/m2
- Control group adults with no diabetes or increased risk, BMI between 18.5 and 24.5 kg/m2
- Female and male adults, voluntary participation
- Understanding of study explanations and willingness to consent to being informed about unexpected pathological findings
You will not qualify if you...
- Use of medications affecting sugar metabolism in people without type 2 diabetes (e.g., antidiabetics, glucocorticoids)
- Diagnosis of type 1 diabetes or latent autoimmune diabetes (positive GAD or IA2 antibodies)
- Maturity onset diabetes of the young (MODY)
- Decompensated type 2 diabetes (HbA1c >9.6% or fasting glucose >230 mg/dl)
- BMI less than 18.5 or greater than 45 kg/m2
- Presence of non-removable metal devices such as pacemakers, artificial heart valves, metal prostheses, implanted magnetic parts, coils, metal splinters, fixed braces or retainers covering more than four teeth, acupuncture needles, insulin pumps, or intraports
- Pregnancy or breastfeeding
- Impaired temperature sensation or increased sensitivity to heat
- Symptomatic coronary heart disease, heart failure greater than NYHA 3, or previous heart attack
- History of stroke
- Hearing disorders or sensitivity to loud noises
- Claustrophobia
- Minors or individuals unable to give consent
- Surgery within the last 3 months
- Acute illness or infection within the last 4 weeks
- Severe neurological or psychiatric disorders (e.g., severe depression, schizophrenia, bipolar disorder)
- Use of centrally acting drugs
- Malignant disease within the last 5 years
- Pancreatic diseases
- Systemic infection (CRP >1 mg/dl)
- Previous bariatric surgery
- Antibiotic therapy within the last 4 weeks before inclusion
- No consent to be informed about unexpected pathological findings
- Participation in interventional trials with investigational medication within the last 30 days
- Severe diabetic complications like advanced chronic kidney disease or severe proliferative retinopathy
- Low hemoglobin levels (Hb <10.5 g/dl for women, Hb <11.5 g/dl for men)
- Other medical conditions that may risk participant safety or study success
- Allergies to any substances used in the study
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Hospital Tübingen
Tübingen, Germany, 72076
Actively Recruiting
Research Team
S
Stephanie Kullmann, Prof.
CONTACT
C
Christian Kübler, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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