Characterization of the Variability of Insulin Secretory Parameters in the Meal Tolerance and the Maximal Stimulation Tests of Healthy Subjects

NCT01454973 | Completed

• 1 other identifier: Beta Cell - Protocol 1a
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

type 2 diabetes; beta cell function; meal tolerance test; maximum stimulation test; method standardization; insulin secretion

Study Arms (1)

Healthy obese individuals

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Healthy obese individuals

You may qualify if:

• Ability to give informed consent and comply with all study requirements
• 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.
• 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.
• 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
• BMI 27-40; stable weight (less than 3% change in past 3 months) Age Range: 30-65
• No history of diabetes mellitus or impaired glucose tolerance (and impaired fasting glucose)

You may not qualify if:

• Subjects presenting with any of the following will not be included in the study:
• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic or clinical findings at Screening.
• Any condition possibly affecting absorption (eg, gastrectomy, malabsorption syndromes, abdominal surgery other than appendectomy, cholecystectomy or hysterectomy).
• Use of unacceptable medications (see Appendix A)
• A positive urine drug screen.
• History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for men (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of Screening.
• Treatment with an investigational drug within 30 days or 5 half-lives preceding the first dose of study medication.
• lead ECG demonstrating QTc \>450 msec at Screening for males, 470 msec for females. If QTc exceeds 450/470 msec, the ECG should be repeated two more times and the average of the three QTc values should be used to determine the subject's eligibility.
• Supine blood pressure \>=140 mm Hg (systolic) or 90 mm Hg (diastolic), on a single measurement. If elevated, confirm by a single repeat, following at least 10 minutes of rest.
• Screening fasting serum glucose \>=100 mg/dL or HbA1c \>6.5%, confirmed by a single repeat if deemed necessary.
• Abnormal oral glucose tolerance test (see below for definition of abnormal).
• Screening serum alanine transaminase (ALT) or serum aspartate transaminase (AST) greater than 2X the upper limit of the laboratory reference range.
• Elevated fasting triglycerides at screening (\>500 mg/dL), confirmed by a single repeat if deemed necessary.
• Pregnant or nursing females; inability to use effective contraception.
• Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.

Sponsors & Collaborators

• Foundation for the National Institutes of Health: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Juvenile Diabetes Research Foundation: collaborator
• Amylin Pharmaceuticals, LLC.: collaborator
• Merck Sharp & Dohme LLC: collaborator
• Pfizer: collaborator
• Eli Lilly and Company: collaborator
• Takeda: collaborator
• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: collaborator
• Novartis: collaborator

Study Sites (1)

ICON Development Solutions, Gault Lane

San Antonio, Texas, 78209, United States

Location

Related Publications (2)

• Ruetten H, Gebauer M, Raymond RH, Calle RA, Cobelli C, Ghosh A, Robertson RP, Shankar SS, Staten MA, Stefanovski D, Vella A, Wright K, Fryburg DA; Foundation for the NIH Biomarkers Consortium Beta Cell Project Team. Mixed Meal and Intravenous L-Arginine Tests Both Stimulate Incretin Release Across Glucose Tolerance in Man: Lack of Correlation with beta Cell Function. Metab Syndr Relat Disord. 2018 Oct;16(8):406-415. doi: 10.1089/met.2018.0022. Epub 2018 Aug 17.

  PMID: 30117761 DERIVED

• Shankar SS, Vella A, Raymond RH, Staten MA, Calle RA, Bergman RN, Cao C, Chen D, Cobelli C, Dalla Man C, Deeg M, Dong JQ, Lee DS, Polidori D, Robertson RP, Ruetten H, Stefanovski D, Vassileva MT, Weir GC, Fryburg DA; Foundation for the National Institutes of Health beta-Cell Project Team. Standardized Mixed-Meal Tolerance and Arginine Stimulation Tests Provide Reproducible and Complementary Measures of beta-Cell Function: Results From the Foundation for the National Institutes of Health Biomarkers Consortium Investigative Series. Diabetes Care. 2016 Sep;39(9):1602-13. doi: 10.2337/dc15-0931. Epub 2016 Jul 12.

  PMID: 27407117 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• George Atiee, M.D.

  ICON Development Solutions

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2011
• First Posted: October 19, 2011
• Study Start: October 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: August 10, 2012

Record last verified: 2012-08

Locations

US (1)