Clinical trial

The Effect of Central Insulin on Insulin Sensitivity and Energy Metabolism

Name
Centrin
Description
Insulin has a direct effect on the energy metabolism of the brain under basal conditions and has an effect on the hepatic glucose production, lipid metabolism and the secretion of various hormone. The effect of intranasal insulin on peripheral metabolism in humans supposedly is mediated by the vagus nerve. The purpose of this study is to determine whether central insulin influences the human peripheral insulin sensitivity of liver and muscle and whether vagus nerve stimulation can mimick this effect.
Trial arms
Trial start
2011-08-01
Estimated PCD
2014-01-01
Trial end
2014-06-01
Status
Completed
Phase
Early phase I
Treatment
intransal insulin
4x 40mU intranasal insulin
Arms:
intranasal insulin in patients, intransal insulin in study participants
Other names:
intranasal insulin
Placebo
Arms:
placebo in patients, placebo in study participants
Other names:
intranasal placebo spray
taVNS
Arms:
taNVS
Other names:
transcutaneous auricular vagus nerve stimulation
sham stimulation
Arms:
Sham stimulation
Other names:
sham stimulation in the ear lobe
Size
30
Primary endpoint
Insulin sensitivity
6 months
Eligibility criteria
Inclusion Criteria: * Age ≥ 30 and ≤ 70 years * balanced gender ratio (50: 50) * BMI 20-25 kg/m² (normal weight subjects) * BMI 25-35 kg/m² (obese subjects) Exclusion Criteria: * acute illness within the last 2 weeks before the examination * autoimmune diseases and disorders immune- compromised (leukocytes \<5000/μl) * renal insufficiency (creatinine\> 1.5 mg / dl) * heart disease, condition after heart attack * anemia (Hb \<12 g / l, controls at each examination), blood donation within 4 weeks before the examination * participation in another study within 2 months before the examination * wear a metal or magnetic objects on or in the body * claustrophobia * use of immunomodulatory drugs (cortisol, antihistamines, aspirin) * thyroid disease * taking glitazones and insulin therapy * pregnancy, lactation, menstruation * cigarette smoking, use of alcohol or drugs, psychiatric disorders * risk for / or manifest AIDS (HIV) or hepatitis B or C * liver disease is not attributed to the existence of a non-alcoholic steatosis * night shift work or circumstances, which do not allow the normal day-night rhythm * bleeding disorders or disorders in wound healing * hypersensitivity to local anesthetics * malignant cancer * heart rhythm disorders * polyneuropathy
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 30, 'type': 'ACTUAL'}}
Updated at
2023-06-05

1 organization

1 product

1 drug

1 indication

Indication
Diabetes