The Electroretinogram in Healthy and Glucose Intolerant Young Men

This study has been completed.
Sponsor:
Information provided by:
Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:
NCT01140932
First received: June 8, 2010
Last updated: December 7, 2010
Last verified: December 2010

June 8, 2010
December 7, 2010
February 2010
June 2010   (final data collection date for primary outcome measure)
ERG [ Time Frame: 12 days ] [ Designated as safety issue: No ]
Characteristics of the scotopic ERG at normo-/hyperglycaemia before vs. after prednisolone treatment
Same as current
Complete list of historical versions of study NCT01140932 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
The Electroretinogram in Healthy and Glucose Intolerant Young Men
Electroretinographic Changes in Healthy Young Men Before and After Induction of Glucose Intolerance by Glucocorticoids Treatment, Hyperphagia and Lack of Exercise

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Electroretinography
  • Drug: Prednisolone
    12 days of corticosteroids treatment (prednisolone 37,5 mg/day)
    Other Name: Prednisolon DAK, Nycomed, Zurich, Switzerland
  • Behavioral: 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
Experimental: Intervention
Medical and behavioural intervention
Interventions:
  • Drug: Prednisolone
  • Behavioral: Lifestyle change
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
June 2010
June 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Caucasians without type 2 diabetes mellitus
  • Normal OGTT (75 g glucose dissolved in 250 mL water) according to WHO's criteria
  • BMI 20-30
  • Haemoglobin > 8,0 mM

Exclusion Criteria:

  • Nephropathy (s-creatinin > 130 µM or albuminuria)
  • Relatives (parents or sibling with T2DM)
  • Medical treatment which cannot be paused for 12 hours
Male
18 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01140932
Kappelgaard, ERG
Yes
Michael Larsen, MD, DMsc, Glostrup University Hospital,Copenhagen
Glostrup University Hospital, Copenhagen
Not Provided
Principal Investigator: Michael Larsen, MD, DMsc Glostrup University Hospital, Copenhagen
Glostrup University Hospital, Copenhagen
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP