The Electroretinogram in Healthy and Glucose Intolerant Young Men

Electroretinography Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01140932
• Other study ID #: Kappelgaard, ERG
• Status: Completed
• Phase: N/A
• First received: June 8, 2010
• Last updated: December 7, 2010
• Start date: February 2010
• Est. completion date: June 2010

Study information

• Verified date: December 2010
• Source: Glostrup University Hospital, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Electroretinography
• Glucose Intolerance

Intervention

Drug:
• Prednisolone
12 days of corticosteroids treatment (prednisolone 37,5 mg/day)

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)

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital at Glostrup	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Glostrup University Hospital, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ERG	Characteristics of the scotopic ERG at normo-/hyperglycaemia before vs. after prednisolone treatment	12 days	No
Secondary	Retinal Vessel Caliber	Measurement of retinal vessel caliber from fundus photographs before and after treatment with glucocorticoids.	12 days	No