Insulin Detemir in Obesity Management

• Status: Active, not recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University
• Collaborator: Novo Nordisk A/S
• Treatments: Insulin; Insulin Detemir; Insulin, Globin Zinc; Neurotransmitter Agents

Criteria

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