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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01140932

Enrollment

Registered

2010-06-10

Start date

2010-02-28

Completion date

2010-06-30

Last updated

2010-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Electroretinography

Keywords

Retina, Electroretinography, Diabetes Mellitus, Glucose Intolerance, Physiology

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.

Interventions

DRUGPrednisolone

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

BEHAVIORALLifestyle change

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 35 Years

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

Design outcomes

Primary

Measure	Time frame	Description
ERG	12 days	Characteristics of the scotopic ERG at normo-/hyperglycaemia before vs. after prednisolone treatment

Secondary

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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026