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

22 luglio 2015 aggiornato da: 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).

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

64

Fase

  • Fase 1

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 35 anni a 75 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Altri nomi:
  • HTZ
Droga: Comparator: Placebo to HCTZ
Placebo to HCTZ two 0 mg capsules once daily for 4 weeks per treatment period
Sperimentale: 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.
Altri nomi:
  • HTZ
Droga: Comparator: Placebo to HCTZ
Placebo to HCTZ two 0 mg capsules once daily for 4 weeks per treatment period
Sperimentale: 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
Sperimentale: 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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Part I: Change in Insulin Secretion at Steady-state Compared to Placebo in Participants With Impaired Glucose Tolerance (IGT)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Part I: Change in the Ratio of Whole Body Glucose Disposal to Plasma Insulin at Steady State in Participants With Impaired Glucose Tolerant (IGT)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Merck Sharp & Dohme LLC

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 marzo 2009

Completamento primario (Effettivo)

1 febbraio 2010

Completamento dello studio (Effettivo)

1 marzo 2010

Date di iscrizione allo studio

Primo inviato

27 marzo 2009

Primo inviato che soddisfa i criteri di controllo qualità

27 marzo 2009

Primo Inserito (Stima)

30 marzo 2009

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

28 luglio 2015

Ultimo aggiornamento inviato che soddisfa i criteri QC

22 luglio 2015

Ultimo verificato

1 luglio 2015

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 0000-117
  • 2009_567

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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