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Insulin
Detemir for Obesity (IDIOM Trial)
N/A
Waitlist Available
Led By Kevin D Niswender, MD/PhD
Research Sponsored by Vanderbilt University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 26 weeks
Awards & highlights
IDIOM Trial Summary
This trial is evaluating the effects of insulin detemir on weight, brain function, and mood in people with obesity.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include changes in blood sugar levels due to insulin use which could lead to hypoglycemia (low blood sugar) or hyperglycemia (high blood sugar), as well as possible discomfort from injections.
IDIOM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 26 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~26 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Diabetes Mellitus, Non-Insulin-Dependent
Secondary outcome measures
Neuropsychiatric functions
Side effects data
From 2017 Phase 4 trial • 157 Patients • NCT0196697850%
GI
18%
headache
16%
Other AE
7%
Diabetic Ketoacidosis
4%
Respiratory Distress
4%
Pneumonia
4%
Fall
2%
nasopharyngeal carcinoma
2%
myocardial infarction
2%
Facial Burn
2%
Urinary Tract Infection
2%
Small Bowel Obstruction
2%
Osteomyelitis
2%
bacteremia
2%
puncture wound
2%
nephrotic syndrome
2%
Lower GI bleed
100%
80%
60%
40%
20%
0%
Study treatment Arm
Control: Metformin, Insulin Detemir, Insulin Aspart
Metformin, Insulin Determir, Liraglutide
IDIOM Trial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Insulin detemir
FDA approved
Find a Location
Who is running the clinical trial?
Vanderbilt UniversityLead Sponsor
703 Previous Clinical Trials
6,143,107 Total Patients Enrolled
34 Trials studying Obesity
6,980 Patients Enrolled for Obesity
Novo Nordisk A/SIndustry Sponsor
1,514 Previous Clinical Trials
2,414,825 Total Patients Enrolled
141 Trials studying Obesity
131,798 Patients Enrolled for Obesity
Kevin D Niswender, MD/PhDPrincipal InvestigatorVanderbilt University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Insulin Detemir Treatment
- Group 2: Comparator: No insulin
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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