The Electroretinogram in Healthy and Glucose Intolerant Young Men

NCT ID: NCT01140932

Last Updated: 2010-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Electroretinography

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Retina Electroretinography Diabetes Mellitus Glucose Intolerance Physiology

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention

Medical and behavioural intervention

Group Type EXPERIMENTAL

Prednisolone

Intervention Type DRUG

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

Lifestyle change

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Prednisolone

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

Intervention Type DRUG

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)

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Prednisolon DAK, Nycomed, Zurich, Switzerland Behavioral regimen

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Glostrup University Hospital, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Glostrup University Hospital,Copenhagen

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michael Larsen, MD, DMsc

Role: PRINCIPAL_INVESTIGATOR

Glostrup University Hospital, Copenhagen

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Copenhagen University Hospital at Glostrup

Copenhagen, Copenhagen, Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Kappelgaard, ERG

Identifier Type: -

Identifier Source: org_study_id