Effect of Sitagliptin on Short-Term Metabolic Dysregulation of Oral Glucocorticoid Therapy
NCT ID: NCT01488279
Last Updated: 2018-03-12
Study Results
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View full resultsBasic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2012-09-30
2015-12-31
Brief Summary
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Detailed Description
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Previous studies have shown that in humans, glucocorticoid-induced insulin resistance develops within 4 hours with infused drug at high dose (methylprednisolone 500 mg x single infusion) and does not change with duration of drug therapy of up to 3 months.10 Furthermore, more modest doses over a short duration (dex 2.0 mg orally daily x 2 days) have been shown to decrease insulin-mediated glucose disposal.11 12 Thus, studying acute effects of oral dex at 2.5 mg daily x 7 days should be more than adequate to achieve impaired glucose-mediated insulin secretion and impaired insulin-mediated glucose disposal.
In order for sitagliptin to have the desired effect, drug should be administered for at least 7 days (5 half-lives plus 40% more for margin of error). We plan to study subjects with impaired fasting glucose or impaired glucose tolerance as they would likely be candidates for DPP-IV therapy in the future and would be likely to have impaired insulin secretion and impaired glucose disposal amenable to DPP-IV therapy.
A total of 10 participants were enrolled in this study. Participants were given 2.5 mg dexamethasone daily plus either placebo tablet or sitagliptin daily for 8 days with a washout period prior to crossover. The order of study drug administration was randomized. Participants underwent blood sampling, mixed meal testing (MMT), and intravenous glucose tolerance testing (IVGTT) before and after each study period.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Dexamethasone 2.5mg and Sitagliptin100mg
Participants received Dexamethasone 2.5 mg plus Sitagliptin 100 mg daily for 8 days
Dexamethasone 2.5 mg and Sitagliptin 100 mg
Participants received Dexamethasone 2.5mg plus Sitaliptin 100mg daily for 8 days
Dexamethasone 2.5 mg and placebo tablet
Participants rececived Dexamethasone 2.5 mg plus placebo tablet daily for 8 days
Dexamethasone 2.5mg and placebo tablet
Participants received Dexamethasone 2.5 mg plus Sitagliptin-matched placebo tablet daily for 8 days.
Dexamethasone 2.5 mg and Sitagliptin 100 mg
Participants received Dexamethasone 2.5mg plus Sitaliptin 100mg daily for 8 days
Dexamethasone 2.5 mg and placebo tablet
Participants rececived Dexamethasone 2.5 mg plus placebo tablet daily for 8 days
Interventions
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Dexamethasone 2.5 mg and Sitagliptin 100 mg
Participants received Dexamethasone 2.5mg plus Sitaliptin 100mg daily for 8 days
Dexamethasone 2.5 mg and placebo tablet
Participants rececived Dexamethasone 2.5 mg plus placebo tablet daily for 8 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* impaired fasting glucose
* We will stratify for weight and age.
Exclusion Criteria
* Severe disease preventing participation in study
* On chronic steroids for any reason
* Already taking DPP-4 inhibitor
18 Years
65 Years
ALL
Yes
Sponsors
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University of Vermont
OTHER
Responsible Party
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Annis Marney, MD, MSCI
Assistant Professor of Medicine
Principal Investigators
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Annis M Marney, MD, MSCI
Role: PRINCIPAL_INVESTIGATOR
University of Vermont
Locations
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University of Vermont Clinical Research Center
South Burlington, Vermont, United States
Countries
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Other Identifiers
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MISP 39681
Identifier Type: -
Identifier Source: org_study_id
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