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Multiple Dose Effects of Hydrochlorothiazide and Isosorbide Mononitrate on Glucose Homeostasis (MK-0000-117)(Completed)

22 de julio de 2015 actualizado por: Merck Sharp & Dohme LLC

A Randomized, Double-Blind, Placebo-Controlled, 2-Part Study to Evaluate the Multiple Dose Effects of Hydrochlorothiazide and Isosorbide Mononitrate on Glucose Homeostasis in Obese Patients With Hypertension

This study will measure and compare changes in insulin production and sensitivity using the hyperglycemic clamp technique in obese patients with impaired glucose tolerance and hypertension treated with placebo, isosorbide mononitrate (ISMN) or hydrochlorothiazide (HCTZ).

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

64

Fase

  • Fase 1

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

35 años a 75 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Female participants must be post-menopausal
  • Body Mass Index (BMI) of at least 29 kg/m^2
  • Weight has been stable over the past 3 months
  • Has never been treated for hypertension or is diagnosed with hypertension taking up to 2 anti-hypertensive medications
  • Willing to stop hypertension treatment for 14 days prior to randomization and throughout the study
  • Does not have a history of diabetes
  • In good health with the exception of hypertension
  • No history of abnormal heart rhythms
  • Part I only: willing to comply with high potassium/low sodium diet for the duration of the study
  • Willing to avoid strenuous physical activity during the study
  • Nonsmoker and/or has not used nicotine for at least 3 months and agrees to refrain from use of tobacco-containing products throughout the study
  • Agrees to refrain from consuming alcohol and caffeine during in-patient periods and to limit consumption at all other times during the study
  • Agrees not to consume grapefruit, grapefruit products, and citrus, apple, and pineapple juices 2 weeks prior to administration of the first dose of study drug

Exclusion Criteria:

  • History of any illness that may make their participation in the study unsafe or confuse the study results
  • Taking spironolactone or eplerenone
  • Cannot refrain from using any prescription or non-prescription drugs during the study
  • On a weight loss program and is not in the maintenance phase
  • Started a weight loss drug within 8 weeks of the first study visit
  • Consumes excessive amounts of alcohol or caffeine
  • Has had major surgery, donated or lost 1 unit of blood within 4 weeks of the first study visit
  • History of multiple and/or severe allergies to drugs or food
  • Is dehydrated

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Part I, Placebo-HCTZ
Placebo in Period 1 followed by HCTZ in Period 2
Droga: Hydrochlorothiazide (HCTZ)
HCTZ 50 mg (two 25 mg capsules) once daily for 4 weeks per treatment period.
Otros nombres:
  • HCTZ
Droga: Comparator: Placebo to HCTZ
Placebo to HCTZ two 0 mg capsules once daily for 4 weeks per treatment period
Experimental: Part I, HCTZ-Placebo
HCTZ in Period 1, followed by placebo in Period 2
Droga: Hydrochlorothiazide (HCTZ)
HCTZ 50 mg (two 25 mg capsules) once daily for 4 weeks per treatment period.
Otros nombres:
  • HCTZ
Droga: Comparator: Placebo to HCTZ
Placebo to HCTZ two 0 mg capsules once daily for 4 weeks per treatment period
Experimental: Part II, Placebo-ISMN
Placebo in Period 1, followed by ISMN in Period 2
Droga: Isosorbide mononitrate (ISMN)
ISMN 60 mg extended release capsule once daily for 4 weeks per treatment period
Droga: Comparator: Placebo to ISMN
Placebo to ISMN 0 mg capsule once daily for 4 weeks per treatment period
Experimental: Part II, ISMN-Placebo
ISMN in Period 1, followed by placebo in Period 2
Droga: Isosorbide mononitrate (ISMN)
ISMN 60 mg extended release capsule once daily for 4 weeks per treatment period
Droga: Comparator: Placebo to ISMN
Placebo to ISMN 0 mg capsule once daily for 4 weeks per treatment period

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Part I: Change in Insulin Secretion at Steady-state Compared to Placebo in Participants With Impaired Glucose Tolerance (IGT)
Periodo de tiempo: 90 -120 minutes post-dose
Steady state was defined as 90-120 minutes post-dose. IGT was defined as a 2 hour plasma glucose >= 140 and <= 199 mg/dL during a 75g oral glucose tolerance test at screening.
90 -120 minutes post-dose
Part I: Change in Insulin Secretion at Steady-state Compared to Placebo in Participants With Impaired Fasting Glucose (IFG)
Periodo de tiempo: 90 -120 minutes post-dose
Steady state was defined as 90-120 minutes post-dose. IFG was defined as fasting plasma glucose (FPG) between 100 and 125 mg/dL at screening.
90 -120 minutes post-dose
Part I: Change in Insulin Secretion at Steady-state Compared to Placebo in Participants Who Had Normal Glucose Tolerance (NGT)
Periodo de tiempo: 90 -120 minutes post-dose
Steady state was defined as 90-120 minutes post-dose. NGT participants (FPG <100 mg/dL & 2 hour plasma glucose (PG) <140 mg/dL during a 75g oral glucose tolerance test (OGTT) at screening) were neither Impaired Glucose Tolerant (IGT) nor Impaired Fasting Glucose (IFG). IGT was defined as a 2 hour plasma glucose >= 140 and <= 199 mg/dL during a 75g oral glucose tolerance test at screening. IFG was defined as FPG between 100 and 125 mg/dL at screening.
90 -120 minutes post-dose
Part II: Ratio of Whole Body Glucose Disposal to Plasma Insulin at Steady-state
Periodo de tiempo: 90 -120 minutes post-dose
Steady state was defined as 90-120 minutes post-dose. The ratio was the quantity of glucose disposed by the body per kg body weight per minute at steady state divided by the approximate steady state plasma insulin concentration. The approximate steady state plasma insulin concentration was estimated by the time-weighted average of the insulin concentration measured at 10 minute intervals in which time = 90, 100, 110, and 120 minutes.
90 -120 minutes post-dose

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Part I: Change in the Ratio of Whole Body Glucose Disposal to Plasma Insulin at Steady State in Participants With Impaired Glucose Tolerant (IGT)
Periodo de tiempo: 90 -120 minutes post-dose
Steady state was defined as 90-120 minutes post-dose. The ratio was the quantity of glucose disposed by the body per kg body weight per minute at steady state divided by the approximate steady state plasma insulin concentration. The approximate steady state plasma insulin concentration was estimated by the time-weighted average of the insulin concentration measured at 10 minute intervals in which time = 90, 100, 110, and 120 minutes. IGT was defined as a 2 hour plasma glucose >= 140 and <= 199 mg/dL during a 75g oral glucose tolerance test at screening.
90 -120 minutes post-dose
Part I: Change in the Ratio of Whole Body Glucose Disposal to Plasma Insulin at Steady State in Participants With Impaired Fasting Glucose (IFG)
Periodo de tiempo: 90 -120 minutes post-dose
Steady state was defined as 90-120 minutes post-dose. The ratio was the quantity of glucose disposed by the body per kg body weight per minute at steady state divided by the approximate steady state plasma insulin concentration. The approximate steady state plasma insulin concentration was estimated by the time-weighted average of the insulin concentration measured at 10 minute intervals in which time = 90, 100, 110, and 120 minutes. IFG was defined as fasting plasma glucose (FPG) between 100 and 125 mg/dL at screening.
90 -120 minutes post-dose
Part I: Change in the Ratio of Whole Body Glucose Disposal to Plasma Insulin at Steady State in Participants With Normal Glucose Tolerant (NGT)
Periodo de tiempo: 90 -120 minutes post-dose
Steady state was defined as 90-120 minutes post-dose. The ratio was the measure of the quantity of glucose disposed per unit of plasma insulin concentration (PIC). Approximate PIC was estimated by the time-weighted average of the insulin concentration measured at 10 minute intervals, time = 90, 100, 110, and 120 minutes. NGT participants (FPG <100 mg/dL & 2 hour PG <140 mg/dL during a 75g OGTT at screening) were neither IGT nor IFG at screening. IGT - defined as a 2 hour PG >= 140 and <= 199 mg/dL during a 75g OGTT at screening. IFG - defined as FPG between 100 and 125 mg/dL at screening.
90 -120 minutes post-dose

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Merck Sharp & Dohme LLC

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de marzo de 2009

Finalización primaria (Actual)

1 de febrero de 2010

Finalización del estudio (Actual)

1 de marzo de 2010

Fechas de registro del estudio

Enviado por primera vez

27 de marzo de 2009

Primero enviado que cumplió con los criterios de control de calidad

27 de marzo de 2009

Publicado por primera vez (Estimar)

30 de marzo de 2009

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

28 de julio de 2015

Última actualización enviada que cumplió con los criterios de control de calidad

22 de julio de 2015

Última verificación

1 de julio de 2015

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 0000-117
  • 2009_567

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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