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The Electroretinogram in Healthy and Glucose Intolerant Young Men

Primary Purpose

Electroretinography

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Prednisolone
Lifestyle change
Sponsored by
Glostrup University Hospital, Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Electroretinography focused on measuring Retina, Electroretinography, Diabetes Mellitus, Glucose Intolerance, Physiology

Eligibility Criteria

18 Years - 35 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Copenhagen University Hospital at Glostrup

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Medical and behavioural intervention

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 8, 2010
Last Updated
December 7, 2010
Sponsor
Glostrup University Hospital, Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT01140932
Brief Title
The Electroretinogram in Healthy and Glucose Intolerant Young Men
Official Title
Electroretinographic Changes in Healthy Young Men Before and After Induction of Glucose Intolerance by Glucocorticoids Treatment, Hyperphagia and Lack of Exercise
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Glostrup University Hospital, Copenhagen

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Electroretinography
Keywords
Retina, Electroretinography, Diabetes Mellitus, Glucose Intolerance, Physiology

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Medical and behavioural intervention
Intervention Type
Drug
Intervention Name(s)
Prednisolone
Other Intervention Name(s)
Prednisolon DAK, Nycomed, Zurich, Switzerland
Intervention Description
12 days of corticosteroids treatment (prednisolone 37,5 mg/day)
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle change
Other Intervention Name(s)
Behavioral regimen
Intervention Description
High calorie diet (130 % of recommended daily energy intake) and relative physical inactivity (no exercise and at least 8 hours of rest/day)
Primary Outcome Measure Information:
Title
ERG
Description
Characteristics of the scotopic ERG at normo-/hyperglycaemia before vs. after prednisolone treatment
Time Frame
12 days
Secondary Outcome Measure Information:
Title
Retinal Vessel Caliber
Description
Measurement of retinal vessel caliber from fundus photographs before and after treatment with glucocorticoids.
Time Frame
12 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Larsen, MD, DMsc
Organizational Affiliation
Glostrup University Hospital, Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Copenhagen University Hospital at Glostrup
City
Copenhagen
ZIP/Postal Code
DK-2600
Country
Denmark

12. IPD Sharing Statement

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The Electroretinogram in Healthy and Glucose Intolerant Young Men

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