The Electroretinogram in Healthy and Glucose Intolerant Young Men
This study has been completed.
Sponsor:
Glostrup University Hospital, Copenhagen
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
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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:
Drug Information available for:
Prednisolone
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Prednisolone sodium phosphate
Prednisolone phosphate
Prednisolone sodium succinate
Methylprednisolone sodium succinate
Dextrose
U.S. FDA Resources
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
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 May 22, 2013