The Electroretinogram in Healthy and Glucose Intolerant Young Men

This study has been completed.
Sponsor:
Information provided by:
Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:
NCT01140932
First received: June 8, 2010
Last updated: December 7, 2010
Last verified: December 2010
  Purpose

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.


Condition Intervention
Electroretinography
Drug: Prednisolone
Behavioral: Lifestyle change

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Electroretinographic Changes in Healthy Young Men Before and After Induction of Glucose Intolerance by Glucocorticoids Treatment, Hyperphagia and Lack of Exercise

Resource links provided by NLM:


Further study details as provided by Glostrup University Hospital, Copenhagen:

Primary Outcome Measures:
  • ERG [ Time Frame: 12 days ] [ Designated as safety issue: No ]
    Characteristics of the scotopic ERG at normo-/hyperglycaemia before vs. after prednisolone treatment


Secondary Outcome Measures:
  • Retinal Vessel Caliber [ Time Frame: 12 days ] [ Designated as safety issue: No ]
    Measurement of retinal vessel caliber from fundus photographs before and after treatment with glucocorticoids.


Enrollment: 10
Study Start Date: February 2010
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
Medical and behavioural intervention
Drug: Prednisolone
12 days of corticosteroids treatment (prednisolone 37,5 mg/day)
Other Name: Prednisolon DAK, Nycomed, Zurich, Switzerland
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)
Other Name: Behavioral regimen

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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01140932

Locations
Denmark
Copenhagen University Hospital at Glostrup
Copenhagen, Denmark, DK-2600
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
Investigators
Principal Investigator: Michael Larsen, MD, DMsc Glostrup University Hospital, Copenhagen
  More Information

No publications provided

Responsible Party: Michael Larsen, MD, DMsc, Glostrup University Hospital,Copenhagen
ClinicalTrials.gov Identifier: NCT01140932     History of Changes
Other Study ID Numbers: Kappelgaard, ERG
Study First Received: June 8, 2010
Last Updated: December 7, 2010
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Glostrup University Hospital, Copenhagen:
Retina
Electroretinography
Diabetes Mellitus
Glucose Intolerance
Physiology

Additional relevant MeSH terms:
Glucose Intolerance
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on September 11, 2014