NCT01140932

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

June 8, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 10, 2010

Completed
Last Updated

December 8, 2010

Status Verified

December 1, 2010

Enrollment Period

4 months

First QC Date

June 8, 2010

Last Update Submit

December 7, 2010

Conditions

Electroretinography

Keywords

RetinaElectroretinographyDiabetes MellitusGlucose IntolerancePhysiology

Outcome Measures

Primary Outcomes (1)

  • ERG

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

    12 days

Secondary Outcomes (1)

  • Retinal Vessel Caliber

    12 days

Study Arms (1)

Intervention

EXPERIMENTAL

Medical and behavioural intervention

Drug: PrednisoloneBehavioral: Lifestyle change

Interventions

PrednisoloneDRUG

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

Also known as: Prednisolon DAK, Nycomed, Zurich, Switzerland
Intervention
Lifestyle changeBEHAVIORAL

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

Also known as: Behavioral regimen
Intervention

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Nephropathy (s-creatinin \> 130 µM or albuminuria)
  • Relatives (parents or sibling with T2DM)
  • Medical treatment which cannot be paused for 12 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Copenhagen University Hospital at Glostrup

Copenhagen, Copenhagen, DK-2600, Denmark

Location

MeSH Terms

Conditions

Diabetes MellitusGlucose Intolerance

Interventions

PrednisoloneSonazoid

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperglycemia

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Michael Larsen, MD, DMsc

    Glostrup University Hospital, Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 8, 2010

First Posted

June 10, 2010

Study Start

February 1, 2010

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

December 8, 2010

Record last verified: 2010-12

Locations

DK(1)