The Electroretinogram in Healthy and Glucose Intolerant Young Men
The purpose is to investigate the electroretinogram (ERG) in young, healthy men in the normoglycaemic and hyperglycaemic state before and after intervention with corticosteroids treatment, high calorie diet and exercise restraint.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||Electroretinographic Changes in Healthy Young Men Before and After Induction of Glucose Intolerance by Glucocorticoids Treatment, Hyperphagia and Lack of Exercise|
- ERG [ Time Frame: 12 days ] [ Designated as safety issue: No ]Characteristics of the scotopic ERG at normo-/hyperglycaemia before vs. after prednisolone treatment
- Retinal Vessel Caliber [ Time Frame: 12 days ] [ Designated as safety issue: No ]Measurement of retinal vessel caliber from fundus photographs before and after treatment with glucocorticoids.
|Study Start Date:||February 2010|
|Study Completion Date:||June 2010|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
Medical and behavioural intervention
12 days of corticosteroids treatment (prednisolone 37,5 mg/day)
Other Name: Prednisolon DAK, Nycomed, Zurich, SwitzerlandBehavioral: Lifestyle change
High calorie diet (130 % of recommended daily energy intake) and relative physical inactivity (no exercise and at least 8 hours of rest/day)
Other Name: Behavioral regimen
The subjects will be fasting from midnight the day before the experiment. Standard procedures (including pupil dilation, dark adaptation, and local anaesthetics) are carried out to allow the ERG to be obtained. After electrophysiology, the subject will be clamped at a plasma glucose level of 10 mM (~180 mg/dL) and after a stabilisation period the ERG protocol is repeated.
Each subject is examined twice on two different days. The first day the subjects are normoglycaemic in the morning (first examination) and hyperglycaemic (clamped to 10 mM) throughout the second examination. The second day subjects are also normoglycaemic and hyperglycaemic but shows up after 7-12 days of daily intake of prednisolone, high calorie diet, and exercise restraint.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01140932
|Copenhagen University Hospital at Glostrup|
|Copenhagen, Denmark, DK-2600|
|Principal Investigator:||Michael Larsen, MD, DMsc||Glostrup University Hospital, Copenhagen|