Type 2 Diabetes
Conditions
Keywords
type 2 diabetes, beta cell function, meal tolerance test, maximum stimulation test, method standardization, insulin secretion
Brief summary
A multi-year clinical study to improve tools for measuring the function of insulin-producing beta cells in people with type 2 diabetes mellitus.
Detailed description
A three-year observational study to standardize the meal tolerance and maximum stimulational tests for measuring beta cell function in the clinical setting. It also aims to improve methods for the early prediction of the long-term response to an intervention and for identification of patients at risk for rapid beta cell function deterioration, thereby enabling future clinical studies that examine diabetes progression.
Interventions
None listed
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Juvenile Diabetes Research Foundation
Amylin Pharmaceuticals, LLC.
Merck Sharp & Dohme LLC
Pfizer
Eli Lilly and Company
Takeda
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Novartis
Foundation for the National Institutes of Health
Study design
Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Ability to give informed consent and comply with all study requirements 2. Overweight and obese, generally healthy men and women. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests. 3. Women of child-bearing potential are allowed (but must agree to use non-hormonal contraception and not plan to become pregnant for the duration of the study. Must agree to maintain the same contraceptive measures throughout the study. Acceptable contraceptive methods for female subjects of childbearing potential include one of the following: * Abstinence. * One (1) of the following methods: * Tubal ligation * Copper-containing intrauterine device (IUD) * Condom AND spermicidal foam/gel/film/cream/suppository * Male partner who has had a vasectomy for at least 6 months. 4. It is required that all male subjects use an acceptable method of contraception (as outlined below), starting from the first dose of study medication and continuing for at least 28 days after the last dose of study drug: * Abstinence * A condom AND one of the following: * Vasectomy for more than 6 months. Female partner who meets one of the following conditions: has had a tubal ligation, hysterectomy, or bilateral oophorectomy; or is post menopausal 5. BMI 27-40; stable weight (less than 3% change in past 3 months) Age Range: 30-65 6. No history of diabetes mellitus or impaired glucose tolerance (and impaired fasting glucose) 7. Other conditions may be allowed, if medically stable and controlled within acceptable limits, including: hypertension, dyslipidemia, osteoarthritis, osteoporosis 8. Smokers allowed, but must be able to participate on inpatient stay and not smoke 9. Normal oral glucose tolerance test response (see
Exclusion criteria
)
Countries
United States
Outcome results
None listed