The Electroretinogram in Healthy and Glucose Intolerant Young Men

Not Applicable

Completed

• Conditions: Electroretinography
• Interventions: Drug: Prednisolone; Behavioral: Lifestyle change

• Registration Number: NCT01140932
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2010-02
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Study First Submitted: 2010-06-08
• Study First Submitted QC: 2010-06-09
• Study First Posted: 2010-06-10
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-07
• Last Update Posted: 2010-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Prednisolone	Medical and behavioural intervention
Intervention	Lifestyle change	Medical and behavioural intervention

Primary Outcome Measures

Name	Time	Method
ERG	12 days	Characteristics of the scotopic ERG at normo-/hyperglycaemia before vs. after prednisolone treatment

Secondary Outcome Measures

Name	Time	Method
Retinal Vessel Caliber	12 days	Measurement of retinal vessel caliber from fundus photographs before and after treatment with glucocorticoids.

Trial Locations

Locations (1)

Copenhagen University Hospital at Glostrup; 🇩🇰 Copenhagen, Denmark