The Electroretinogram in Healthy and Glucose Intolerant Young Men
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01140932|
Recruitment Status : Completed
First Posted : June 10, 2010
Last Update Posted : December 8, 2010
|Condition or disease||Intervention/treatment||Phase|
|Electroretinography||Drug: Prednisolone Behavioral: Lifestyle change||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (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|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||June 2010|
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
- ERG [ Time Frame: 12 days ]Characteristics of the scotopic ERG at normo-/hyperglycaemia before vs. after prednisolone treatment
- Retinal Vessel Caliber [ Time Frame: 12 days ]Measurement of retinal vessel caliber from fundus photographs before and after treatment with glucocorticoids.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01140932
|Copenhagen University Hospital at Glostrup|
|Copenhagen, Denmark, DK-2600|
|Principal Investigator:||Michael Larsen, MD, DMsc||Glostrup University Hospital, Copenhagen|