Incretin Effect in People With Impaired Fasting Glucose

Exploring the Incretin Effect in People With IFG

Patrocinadores

Patrocinador principal: University of Colorado, Denver

Fuente University of Colorado, Denver
Resumen breve

Regulation of endogenous glucose production (EGP) and insulin secretion are major actions of glucagon-like peptide-1 (GLP-1). Determining whether alterations in GLP-1 may contribute to abnormal EGP and insulin secretion in people with impaired fasting glucose (IFG) was the objective of the current study. The investigators hypothesized that defects in GLP-1 may explain the inappropriate basal EGP and diminished insulin secretion in IFG, and, furthermore, that by increasing circulating GLP-1 levels (using a new medicine called "sitagliptin") the investigators could reverse these defects.

Estado general Completed
Fecha de inicio January 2008
Fecha de Terminación November 2008
Fecha de finalización primaria August 2008
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Baseline and change in endogenous glucose production 28 days
Baseline and change in insulin secretion 28 days
Resultado secundario
Medida Periodo de tiempo
Insulin secretion in response to oral vs. IV glucose baseline
Baseline and change in hormones, substrates and insulin action 28 days
Inscripción 23
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: Januvia (sitagliptin phosphate)

Descripción: Januvia 100 mg po qd x 28 days for all subjects after baseline measures made

Elegibilidad

Criterios:

Inclusion Criteria:

- Healthy, sedentary, non-smokers, men and women 45-70 years old Subjects were placed into 1 of the 2 groups based on two 2-hour 75g oral glucose tolerance tests (2h OGTT), separated by one week: a control group with normal glucose tolerance (NGT; n=14; fasting glucose <5.6 mmol/l and 2h OGTT <7.8 mmol/l), or IFG (n=10; fasting glucose 5.6-6.9 mmol/l, and 2h OGTT <7.8 mmol/l).

Exclusion Criteria:

- Subjects were excluded for: thyroid stimulating hormone <50 or >500 mU/l, fasting triglycerides >10.3 mmol/l, creatinine >130 μmol/l, elevated liver function tests (>2X normal), hematocrit < 38%, or WBC<3.0 x 103. Use of medications for lipid and/or glucose lowering also excluded enrollees. Women may not have used hormone replacement therapy in the past 1 year. Smokers. BMI <25 or >40 kg/m2. Diabetes or impaired glucose tolerance.

Género: All

Edad mínima: 45 Years

Edad máxima: 70 Years

Voluntarios Saludables: Accepts Healthy Volunteers

Oficial general
Apellido Papel Afiliación
Leigh Perreault, MD Principal Investigator University of Colorado, Denver
Ubicación
Instalaciones: University of Colorado Denver
Ubicacion Paises

United States

Fecha de verificación

November 2008

Fiesta responsable

Tipo: Sponsor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: IFG

Tipo: Experimental

Descripción: people with impaired fasting glucose

Etiqueta: NGT

Tipo: Experimental

Descripción: people with normal glucose tolerance

Acrónimo 1651
Información de diseño del estudio

Asignación: Non-Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov