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Completed

NCT Number: NCT01140932

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.

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Key information

Conditions

Electroretinography Diabetes Mellitus Endocrine System Diseases Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Copenhagen University Hospital at Glostrup

Copenhagen, DK-2600, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prednisolone

Drug

12 days of corticosteroids treatment (prednisolone 37,5 mg/day)

Other names: Prednisolon DAK, Nycomed, Zurich, Switzerland

Lifestyle change

Behavioral

High calorie diet (130 % of recommended daily energy intake) and relative physical inactivity (no exercise and at least 8 hours of rest/day)

Other names: Behavioral regimen

Primary outcomes

  1. ERG

    Time frame: 12 days

    Characteristics of the scotopic ERG at normo-/hyperglycaemia before vs. after prednisolone treatment

Secondary outcomes

  1. Retinal Vessel Caliber

    Time frame: 12 days

    Measurement of retinal vessel caliber from fundus photographs before and after treatment with glucocorticoids.

Sponsors and collaborators

Lead sponsor

Glostrup University Hospital, Copenhagen

Other

Registry information

Official study title

Electroretinographic Changes in Healthy Young Men Before and After Induction of Glucose Intolerance by Glucocorticoids Treatment, Hyperphagia and Lack of Exercise

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jun 10, 2010
Registry last updated
Dec 8, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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