The Electroretinogram in Healthy and Glucose Intolerant Young Men

Sponsor

Glostrup University Hospital, Copenhagen (Other)

Overall Status

Completed

CT.gov ID

NCT01140932

Collaborator

(none)

Enrollment

Location

Arm

3.9

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

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 :

Feb 1, 2010

Actual Primary Completion Date :

Jun 1, 2010

Actual Study Completion Date :

Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Medical and behavioural intervention	Drug: Prednisolone 12 days of corticosteroids treatment (prednisolone 37,5 mg/day) Other Names: 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 Names: Behavioral regimen

Arm

Intervention/Treatment

Experimental: Intervention

Medical and behavioural intervention

Drug: Prednisolone

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

Other Names:

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 Names:

Behavioral regimen

Outcome Measures

Primary Outcome Measures

ERG [12 days]
Characteristics of the scotopic ERG at normo-/hyperglycaemia before vs. after prednisolone treatment

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

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