Could a diabetes shot help your brain fight obesity?
NCT ID NCT01239550
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looks at whether adding the drug insulin detemir to a low-calorie diet helps obese adults with type 2 diabetes lose more weight and improve brain function related to food reward. About 240 people will be split into two groups: one on diet only, the other on diet plus daily insulin shots. The trial lasts 26 weeks and includes brain scans and blood tests.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- insulin detemir (Levemir)
- What this could lead to
- If it works, this could point toward a way to boost weight loss in people with type 2 diabetes by improving brain reward signaling.
- What could go wrong
- This is an early-stage study with only 240 participants, so results may not apply to everyone. Adding insulin carries a risk of low blood sugar.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 240 people
The number the study aims to enrol. It can still change while the study runs.
- Start date
-
Apr 2011
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
31 to 60 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion criteria: 1. Informed consent obtained before any trial-related activities 2. Age at study entry is between 31-60 years of age 3. Body Mass index (BMI) between 30-49 kg/m2 using measured height and weight 4. Body weight \<350lbs (MRI table limit) 5. Stable body weight during the previous 3 months with a less than 5 pounds self -reported weight change 6. Type 2 diabetes, insulin naïve (except for use during gestational diabetes) on either metformin, sitagliptin, or dipeptidyl-4 inhibitor (sitagliptin or saxagliptin), or a thiazolidines (rosiglitazone or pioglitazone) 7. HbA1c level between \~6-8% 8. Lives in a community dwelling and has a telephone 9. Agrees to avoid alcohol and exercise within 48 hours of CRC visits, and to comply with the dietary/stimulant restrictions for 48 hours before PET and fMRI studies. 10. Able and willing to follow prescribed menus plans Exclusion Criteria: 1. Known or suspected hypersensitivity to study drug (insulin detemir) 2. Significant co-morbidities including cardiovascular disease, atherosclerotic disease, pulmonary disease, metabolic disease, liver or renal insufficiency 3. Significant pathologic finding on MRI (research MRI scans are not clinical scans and are not standardly read by a neuroradiologist, but if an overt anomaly is noted by study personnel, an advisory read will be obtained and the patient will be provided with the information for follow-up with his/her physician). 4. Clinically significant abnormalities on screening EKG 5. History of Substance Abuse, including but not exclusive to alcohol, cocaine, marijuana, heroin, nicotine 6. Any tobacco use in last 3 months 7. History of psychiatric disorder deemed too severe to permit participation (PI discretion) including subjects with a lifetime history of lifetime Psychotic Disorder (Schizophrenia, Schizoaffective, Psychosis NOS) or Bipolar Disorder, suicide attempt or history of any suicidal behavior or history within the past 6 months of Post Traumatic Stress Disorder, Generalized Anxiety Disorder 8. Long term use of steroids or medications that may cause weight gain within 3 months of study or in foreseeable need (e.g. uncontrolled asthma or rheumatologic disorder). 9. Inability to abstain from alcohol, physical exercise or \> 1 cup of coffee or equivalent daily for 2 days prior to imaging studies 10. Any contraindication which would interfere with MRI or PET studies, e.g. claustrophobia, cochlear implant, metal fragments in eyes, cardiac pacemaker, neural stimulator, tattoos with iron pigment and metallic body inclusions or other metal implanted in the body 11. Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (abstinence or the following methods: diaphragm with spermicide, condom with spermicide by male partner, intrauterine device, sponge, spermicide, Norplant, Depo-Provera or oral contraceptives) 12. History of uncontrolled thyroid disease evidenced by TSH outside normal range 13. Obesity induced by other endocrinologic disorders (e.g. Cushing Syndrome, Polycystic ovarian syndrome) 14. Previous surgery for weight loss 15. High level aerobic activity such as running for longer than 60 minutes more than 2 times a week regularly in last 3months 16. Significant eating disorder or dietary restraints as determined by three factor eating questionnaire (TFEQ) 17. Appetite reducing diet supplement or herbal supplement use in last 6 months 18. . Food allergy or diet restrictions that would interfere with balanced intake and caloric goals. 19. Dietary supplements of such as EPA, DHA or omega-3 fatty acids. 20. Daily intakes of coffee, black tea and other caffeinated beverages will be assessed and subjects who consume the equivalent of \>4 cups coffee or black tea/day at baseline will be excluded 21. Any condition felt by PI or co-investigators to interfere with ability to complete the study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Vanderbilt University
Nashville, Tennessee, 37232, United States
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