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PREDnisolone-induced Beta-cell Dysfunction Prevented by EXenatide (PREDEX)

This study has been completed.
Sponsor:
Collaborator:
National Research Council, Institute of Biomedical Engineering
Information provided by:
VU University Medical Center
ClinicalTrials.gov Identifier:
NCT00744224
First received: August 28, 2008
Last updated: January 12, 2010
Last verified: January 2010
History of Changes
  Purpose

The purpose of this study is to explore whether the GLP-1 receptor agonist exenatide, may prevent glucocorticoid-induced glucometabolic abnormalities and beta-cell dysfunction in healthy subjects.


Condition Intervention
Glucocorticoid-induced Glucometabolic Abnormalities
Glucocorticoid-induced Beta-cell Dysfunction
 Drug: Placebo
Drug: Prednisolone
Drug: Prednisolone and Exenatide

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Prednisolone-induced Impairment of Glucose Metabolism and Beta-cell Dysfunction and the Protective Effects of Exenatide: a Single-center, Randomized, Double-blind, Placebo-controlled Crossover Study in Healthy Volunteers

Resource links provided by NLM:

MedlinePlus related topics: Steroids
U.S. FDA Resources

Further study details as provided by VU University Medical Center:

Primary Outcome Measures:
  • To assess whether a single day infusion of the GLP-1 RA exenatide, as compared to placebo, reverses GC-induced impairment of glucose metabolism in healthy males, quantified as glucose tolerance (AUCgluc) during a standardized mixed-meal test [ Time Frame: Single-day treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess whether a single day infusion of the GLP-1 RA exenatide, as compared to placebo, reverses GC-induced acute beta-cell dysfunction in healthy males, quantified as Various measures of beta-cell function [ Time Frame: Single day treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 8
Study Start Date: February 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Drug: Placebo
Single dose of placebo with saline infusion
Active Comparator: 2 Drug: Prednisolone
Single dose of 80 mg prednisolone with saline infusion
Active Comparator: 3 Drug: Prednisolone and Exenatide
Prednisolone 80 mg single dose Exenatide infusion 20 mg/min

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • written informed consent
  • 18 years ≤ age ≤ 35 years on the day of the first visit
  • 22.0 ≤ BMI ≤ 28.0 kg/m2
  • (History of) good physical and mental health as determined by history taking, physical and laboratory examinations and ECG.
  • fasting glucose level of < 5.6 mmol/L, in addition to a glucose level of < 7.8 mmol/L at 2 hours after intake of 75 g glucose (OGTT).
  • able to keep a normal day and night rhythm during the trial period (i.e. no shift work)

Exclusion Criteria:

  • history or presence of a medical disorder
  • use of drugs, except for incidental (non-opioid) analgesic agents
  • first degree relative with T2DM
  • performing intensive physical activity > 1x/week
  • an allergic or anaphylactic reaction to prednisolone treatment in the past
  • clinically relevant history or presence of any medical disorder, which are mentioned in the Summary of Product Characteristics (SPC) as contraindication for the use of prednisolone
  • glucocorticosteroid use during the last three months prior to the first dose
  • participation in an investigational drug trial within 90 days prior to the first dose
  • donation of blood (> 100 mL) within 90 days prior to the first dose
  • history of or current abuse of drugs or alcohol (>14 U/week)
  • smoking
  • use of grapefruit products during the study period
  • recent changes in weight and/or physical activity
  • serious mental impairment or language problems i.e. preventing to understand the study protocol/aim
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00744224

Locations
Netherlands
VU University Medical Center
Amsterdam, Noord-Holland, Netherlands, 1081HV
Sponsors and Collaborators
VU University Medical Center
National Research Council, Institute of Biomedical Engineering
Investigators
Principal Investigator: Michaela Diamant, MD PhD VU University Medical Center
  More Information

No publications provided by VU University Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr M Diamant, VU University Medical Center
ClinicalTrials.gov Identifier: NCT00744224     History of Changes
Other Study ID Numbers: DC2008pred003
Study First Received: August 28, 2008
Last Updated: January 12, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Congenital Abnormalities
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Exenatide
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Hypoglycemic Agents

ClinicalTrials.gov processed this record on May 19, 2013