- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01663207
Characterization of the Variability Of Insulin Secretory Parameters in the Meal Tolerance and the Maximal Stimulation Tests of Subjects With Prediabetes
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
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Texas
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San Antonio, Texas, États-Unis, 78209
- ICON Development Solutions, Gault Lane
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- 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
- 2h 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
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 (menopause is defined as over the age of 60 years, or between 45 and 60 years being amenorrheic for at least 2 years with plasma (FSH) level > 30 UI/L) or
- Or for female partners of the male participants, in addition to hysterectomy, oophorectorectomy, or post-menopausal status, that the use of a spermicidal gel or foam will constitute adequate protection in conjunction with use of a condom by the male.
- BMI 27-40; stable weight (less than 3% change in past 3 months) Age Range: 30-65
- No history of diabetes mellitus
- Other conditions may be allowed, if medically stable and controlled for at least four weeks within acceptable limits, including: hypertension, dyslipidemia, osteoarthritis, osteoporosis
- Smokers allowed, but must be able to participate on inpatient stay and not smoke
Exclusion Criteria:
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.
- 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. 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.
- 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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obese individuals with prediabetes
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Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Chercheur principal: George Atiee, MD, ICON Development Solutions
Publications et liens utiles
Publications générales
- 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. Erratum In: Metab Syndr Relat Disord. 2019 Mar;17(2):128.
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Beta Cell - Protocol 1c
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