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. Identifier: NCT01140932
Recruitment Status : Completed
First Posted : June 10, 2010
Last Update Posted : December 8, 2010
Information provided by:
Glostrup University Hospital, Copenhagen

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Electroretinography Drug: Prednisolone Behavioral: Lifestyle change Not Applicable

Detailed Description:

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
Allocation: Non-Randomized
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

Arm Intervention/treatment
Experimental: Intervention
Medical and behavioural intervention
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

Primary Outcome Measures :
  1. ERG [ Time Frame: 12 days ]
    Characteristics of the scotopic ERG at normo-/hyperglycaemia before vs. after prednisolone treatment

Secondary Outcome Measures :
  1. Retinal Vessel Caliber [ Time Frame: 12 days ]
    Measurement of retinal vessel caliber from fundus photographs before and after treatment with glucocorticoids.

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01140932

Copenhagen University Hospital at Glostrup
Copenhagen, Denmark, DK-2600
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
Principal Investigator: Michael Larsen, MD, DMsc Glostrup University Hospital, Copenhagen

Responsible Party: Michael Larsen, MD, DMsc, Glostrup University Hospital,Copenhagen Identifier: NCT01140932     History of Changes
Other Study ID Numbers: Kappelgaard, ERG
First Posted: June 10, 2010    Key Record Dates
Last Update Posted: December 8, 2010
Last Verified: December 2010

Keywords provided by Glostrup University Hospital, Copenhagen:
Diabetes Mellitus
Glucose Intolerance

Additional relevant MeSH terms:
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents