NCT01663207

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 13, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

July 16, 2014

Status Verified

August 1, 2012

Enrollment Period

1.9 years

First QC Date

August 9, 2012

Last Update Submit

July 14, 2014

Conditions

Type 2 Diabetes

Keywords

type 2 diabetesbeta cell functionmeal tolerance testmaximum stimulation testmethod standardizationinsulin secretionprediabetesinsulin sensitivity

Study Arms (1)

obese individuals with prediabetes

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

obese individuals with prediabetes

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 (with the exception of glucose tolerance, see below), full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests.
  • Glucose Parameters:
  • Fasting plasma glucose ≥100 mg/dL and \<126 mg/dL
  • h post-OGTT glucose of ≥140 and \<200 mg/dL
  • HbA1c\<6.5%
  • 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
  • +10 more criteria

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, neoplastic, or allergic or clinical findings at Screening (seasonal allergies OK).
  • Any condition possibly affecting absorption (eg, gastrectomy, malabsorption syndromes, abdominal surgery other than appendectomy, cholecystectomy or hysterectomy).
  • Use of unacceptable medications
  • 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. An ECG with evidence for possible old myocardial infarction will need to have prior ECGs to document stability of finding.
  • 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 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.
  • Participation in a clinical biomedical research study within prior two months may be excluded, depending on study type and details.
  • History of sensitivity to heparin or heparin-induced thrombocytopenia, if utilized by the site for blood draws.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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: 30117761DERIVED

  • 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: 27407117DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Prediabetic StateInsulin Resistance

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Study Officials

  • George Atiee, MD

    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

August 9, 2012

First Posted

August 13, 2012

Study Start

May 1, 2012

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

July 16, 2014

Record last verified: 2012-08

Locations

US(1)