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Incretins in Impaired Fasting Glucose
This study has been completed.
First Received: August 14, 2006   Last Updated: July 31, 2009   History of Changes
Sponsor: Mayo Clinic
Information provided by: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00364377
  Purpose

People with high fasting glucose can develop type 2 diabetes with the passage of time. This study is being done to determine the effect of a novel medication in people with this elevated fasting glucose. Sitagliptin is a substance that raises levels of a hormone normally found in the blood. This hormone, called glucagon-like peptide-1 (GLP-1), is normally released by the intestine in response to the presence of food. This hormone acts like a messenger between the intestine and the pancreas to raise insulin levels, and therefore, lower blood sugars. Sitagliptin is effective in people with diabetes, however, this study is being done to determine if Sitagliptin is effective in people with high fasting glucose who do not yet have diabetes.


Condition Intervention Phase
Impaired Fasting Glucose
Drug: Sitagliptin
Other: Placebo
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: The Role of Incretins in the Pathogenesis of Fasting and Postprandial Glucose Metabolism in People With Impaired Fasting Glucose

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Lowering of fasting glucose [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: August 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
People with impaired fasting glucose treated with sitagliptin 100mg once daily.
Drug: Sitagliptin
100mg once daily
Drug: Sitagliptin
100mg once daily over duration of study
2: Placebo Comparator
People with impaired fasting glucose treated with placebo once daily.
Other: Placebo
once daily for duration of the study

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Twenty four participants aged 35 to 70 years with impaired fasting glucose (100mg/dl-125 mg/dl) will be studied. We will screen up to twice that number i.e. 48 which will allow for dropouts or screen failures. Individuals with a body mass index less than 19 or greater than 40 kg/m2, or a total weight > 130kg, will be excluded from study to avoid potential confounding effects that may result from extreme leanness or obesity. Subjects greater than age 35 years of age will be eligible for study. Subjects less than 35 years will not be studied in order to minimize the possibility of studying subjects with type 1 diabetes. Subjects must be in good health as determined by past medical history and a physical examination inclusive vital signs, electrocardiogram, and laboratory tests at the time of screening. Healthy subjects will mean that the participant has no history of a) significant nephropathy, (i.e., plasma creatinine > 1.4 mg/dl in women and 1.5 mg/dl in men, and/or proteinuria); b) clinically significant atherosclerotic vascular disease (e.g., history of MI or angina); c) a known systemic illness. Patients on diuretics or thyroid hormone therapy must be on a stable dose (at least 3 months prior to screening) and the maintenance dose may not be adjusted during the study

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00364377

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Robert A. Rizza, M.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: Mayo Clinic ( Robert A Rizza MD )
Study ID Numbers: 06-002673
Study First Received: August 14, 2006
Last Updated: July 31, 2009
ClinicalTrials.gov Identifier: NCT00364377     History of Changes
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Prediabetic State
Diabetes Mellitus
Hormones, Hormone Substitutes, and Hormone Antagonists
Endocrine System Diseases
Enzyme Inhibitors
Hormones
Pharmacologic Actions
Sitagliptin
Protease Inhibitors
Dipeptidyl-Peptidase IV Inhibitors
Incretins
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on November 30, 2009