Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2025-12-24 @ 4:51 PM
NCT ID:
NCT01239550
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
31 Years
Maximum Age:
60 Years
Study:
NCT01239550
Study Brief:
Protocol Section:
NCT01239550