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Type 2 DiabetesNCT01454973

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

An observational study of Type 2 Diabetes, run by Foundation for the National Institutes of Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Type 2 Diabetes
How many people
25 participants
Where
1 siteUnited States
Study dates
Oct 2011to Jan 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Healthy obese individuals

Who may be able to join

  • 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
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  • 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)
  • Other conditions may be allowed, if medically stable and controlled within acceptable limits, including: hypertension, dyslipidemia, osteoarthritis, osteoporosis
  • Smokers allowed, but must be able to participate on inpatient stay and not smoke
  • Normal oral glucose tolerance test response (see exclusion criteria)

Who cannot join

  • 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.
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  • Treatment with an investigational drug within 30 days or 5 half-lives preceding the first dose of study medication.
  • 12 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.
  • 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.
  • Unwilling or unable to comply with directions and procedures described in this protocol.
  • Subject is the Investigator or a sub-Investigator, research assistant, pharmacist, study coordinator, other staff, or a relative of study personnel directly involved with the conduct of the study.
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • ICON Development Solutions, Gault Lane

    San Antonio, Texas, 78209

Other trials in United States

About this study

A multi-year clinical study to improve tools for measuring the function of insulin-producing beta cells in people with type 2 diabetes mellitus.

Read the 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.

Conditions
Type 2 Diabetes
Keywords
type 2 diabetes, beta cell function, meal tolerance test, maximum stimulation test, method standardization, insulin secretion
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01454973
Study groupRoleWhat they receive
Healthy obese individualsNot described

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionJan 2012
  4. Study completionJan 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case crossover
Time perspective
Prospective
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01454973
Sponsor's protocol ID
Beta Cell - Protocol 1a
Status last verified
Aug 2012
First submitted
17 Oct 2011
Last updated
10 Aug 2012
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 30117761

  • 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.

    PubMed 27407117

Questions about this trial

What is this clinical trial studying?

An observational study of Type 2 Diabetes, run by Foundation for the National Institutes of Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01454973, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2012.

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