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| Tracking Information | |||||
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| First Received Date ICMJE | August 14, 2006 | ||||
| Last Updated Date | July 31, 2009 | ||||
| Start Date ICMJE | August 2006 | ||||
| Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Lowering of fasting glucose [ Time Frame: 8 weeks ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Lowering of fasting glucose | ||||
| Change History | Complete list of historical versions of study NCT00364377 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Incretins in Impaired Fasting Glucose | ||||
| Official Title ICMJE | The Role of Incretins in the Pathogenesis of Fasting and Postprandial Glucose Metabolism in People With Impaired Fasting Glucose | ||||
| Brief Summary | 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. |
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| Detailed Description | |||||
| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE | Impaired Fasting Glucose | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 24 | ||||
| Completion Date | December 2008 | ||||
| Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | 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 |
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| Gender | Both | ||||
| Ages | 35 Years to 70 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00364377 | ||||
| Responsible Party | Robert A Rizza MD, Mayo Clinic | ||||
| Study ID Numbers ICMJE | 06-002673 | ||||
| Study Sponsor ICMJE | Mayo Clinic | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Mayo Clinic | ||||
| Verification Date | July 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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