Status:
ACTIVE_NOT_RECRUITING
Insulin Detemir in Obesity Management
Lead Sponsor:
Vanderbilt University
Collaborating Sponsors:
Novo Nordisk A/S
Conditions:
Diabetes
Obesity
Eligibility:
All Genders
31-60 years
Phase:
NA
Brief 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 ...
Detailed Description
Together with obesity, diabetes is epidemic in the US (20) and worldwide (21). Increased body weight is both a risk factor for diabetes (22) and a consequence of initiation and intensification of insu...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Informed consent obtained before any trial-related activities
- Age at study entry is between 31-60 years of age
- Body Mass index (BMI) between 30-49 kg/m2 using measured height and weight
- Body weight \<350lbs (MRI table limit)
- Stable body weight during the previous 3 months with a less than 5 pounds self -reported weight change
- 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)
- HbA1c level between \~6-8%
- Lives in a community dwelling and has a telephone
- 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.
- Able and willing to follow prescribed menus plans
- Exclusion Criteria:
- Known or suspected hypersensitivity to study drug (insulin detemir)
- Significant co-morbidities including cardiovascular disease, atherosclerotic disease, pulmonary disease, metabolic disease, liver or renal insufficiency
- 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).
- Clinically significant abnormalities on screening EKG
- History of Substance Abuse, including but not exclusive to alcohol, cocaine, marijuana, heroin, nicotine
- Any tobacco use in last 3 months
- 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
- 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).
- Inability to abstain from alcohol, physical exercise or \> 1 cup of coffee or equivalent daily for 2 days prior to imaging studies
- 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
- 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)
- History of uncontrolled thyroid disease evidenced by TSH outside normal range
- Obesity induced by other endocrinologic disorders (e.g. Cushing Syndrome, Polycystic ovarian syndrome)
- Previous surgery for weight loss
- High level aerobic activity such as running for longer than 60 minutes more than 2 times a week regularly in last 3months
- Significant eating disorder or dietary restraints as determined by three factor eating questionnaire (TFEQ)
- Appetite reducing diet supplement or herbal supplement use in last 6 months
- . Food allergy or diet restrictions that would interfere with balanced intake and caloric goals.
- Dietary supplements of such as EPA, DHA or omega-3 fatty acids.
- 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
- Any condition felt by PI or co-investigators to interfere with ability to complete the study
Exclusion
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT01239550
Start Date
April 1 2011
End Date
December 1 2025
Last Update
June 4 2025
Active Locations (1)
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1
Vanderbilt University
Nashville, Tennessee, United States, 37232