Trial Summary
What is the purpose of this trial?The purpose of this study is to evaluate the effects of the medication insulin detemir on weight, brain function and mood, and on blood vessel and other risk factors for heart disease. The study will compare how diet and insulin detemir affect areas of the brain that are involved in food intake and the sense of pleasure people get from eating.
Participants will be randomized into one of 2 groups. Group 1 will follow a low calorie diet only. Group 2 will follow a low calorie diet and take insulin detemir.
The study is 26 weeks in length and include outpatient visits, inpatient visits, phone and email contact, questionnaires, diary collection, blood draw and procedures involving MRI and PET scans. There are 4 inpatient visits at the Vanderbilt Clinical Research Center (CRC). The inpatient visits require a one night 2 day stay on the CRC at Weeks 2, 6, 16, 26. During the weekly and bi-weekly outpatient visits participants will meet with the study nurse and dietitian.
Eligibility Criteria
Adults aged 31-60 with stable obesity (BMI of 30-49), type 2 diabetes not on insulin, and a weight under 350lbs can join. They must have maintained their weight recently, be willing to follow diet plans, and avoid certain substances before visits. Those with significant health issues or conditions that affect study participation are excluded.Inclusion Criteria
Stable body weight during the previous 3 months with a less than 5 pounds self -reported weight change
Informed consent obtained before any trial-related activities
Age at study entry is between 31-60 years of age
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Exclusion Criteria
Dietary supplements of such as EPA, DHA or omega-3 fatty acids.
Previous surgery for weight loss
Any tobacco use in last 3 months
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Participant Groups
The trial is testing if insulin detemir helps manage obesity when combined with a low-calorie diet compared to the diet alone. It will also look at effects on brain function, mood, heart disease risk factors through outpatient/inpatient visits involving questionnaires and scans over a period of 26 weeks.
2Treatment groups
Experimental Treatment
Active Control
Group I: Insulin Detemir TreatmentExperimental Treatment1 Intervention
Insulin detemir treatment: Insulin detemir will be administered subcutaneously, once daily. Dose ranges from approximately 0.1 U/kg up to 0.6 u/kg or higher. The dosing regimen will employ a strategy similar to the "303"algorithm, where, with close interaction with study personnel (rather than self-titration), bedtime insulin dosing will be titrated up by 3 units until AM fasting sugars within the prescribed protocol range are achieved (90-110 mg/dl). Subjects will have contact with study personnel on weekly basis for glycemia monitoring and adjustments. Similarly, documented hypoglycemia (blood sugars less than 70) will trigger a dose reduction, and it is expected that with weight loss, tolerable insulin dosages will drift downward. The treatment period is 24 weeks.
Group II: Comparator: No insulinActive Control1 Intervention
The main hypothesis is that "diabetes can be changed " with early and careful insulinization capturing effects on brain function ultimately leading to weight loss. . Seek to determine in a quantitative manner whether insulin detemir restores brain dopamine neurotransmission, a control group not treated with insulin is required. The strength of this study is our ability to test the specific molecular (D2R, DAT, functional MRI responses) and integrated output (functional brain responses, mood, cognitive function, reward responses etc.) of CNS dopaminergic pathways in order to shed unprecedented light upon mechanisms of detemir action in obesity and diabetes.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Vanderbilt UniversityNashville, TN
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Who Is Running the Clinical Trial?
Vanderbilt UniversityLead Sponsor
Novo Nordisk A/SIndustry Sponsor