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The Effect of Dietary Fat Load and Physical Exercise on the Flexibility and Partitioning of Ectopic Lipids.
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2014 by University Hospital Inselspital, Berne.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
University Hospital Inselspital, Berne
Collaborator:
Swiss National Science Foundation
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01467193
First received: November 3, 2011
Last updated: September 8, 2014
Last verified: September 2014
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Purpose
This study aims at assessing the effect of standardized dietary fat load and short-term aerobic exercise on systemic lipolysis, flexibility and partitioning of ectopic fat stores (intramyocellular = IMCL, intrahepatocellular = IHCL, intramyocardial lipids = IMCaL) in relation to FFA in endurance trained athletes and hypopituitary patients compared to sedentary healthy control subjects.
Exercise is a powerful stimulation for growth hormone (GH) secretion in health. A standardised exercise test can, therefore, be discriminative for the diagnosis of GH-deficiency in adults. This will be assessed.
Hypothesis (ectopic fat stores)
- Ectopic fats stores are flexible fuel stores and are influenced by diet and physical activity.FFA availability may play an important regulatory role.
- There is a tissue specific partitioning of triglycerides and/or FFA among non-adipose organs after fat load and physical exercise
- The flexibility of ectopic fat stores is related to insulin sensitivity
- Lipolytic and anti-lipolytic hormones are critical for regulating FFA availability (at rest or during exercise) and therefore also for the regulation of ectopic fat stores.
- GH is a lipolytica hormone. Lack of GH in adulthood is related to decreased FFA availability thereby influencing ectopic lipid stores Hypothesis diagnosis of GHD
- A short intensive physical exercise shows a good discriminative power to diagnose GHD.
| Condition | Intervention |
|---|---|
| Ectopic Lipids Insulin Sensitivity Aerobic Exercise Fat Load Growth Hormone Deficiency | Dietary Supplement: Fat diet Other: 2h standardized aerobic exercise |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | The Effect of Dietary Fat Load and Physical Exercise on the Flexibility and Partitioning of Ectopic Lipids. |
Resource links provided by NLM:
Genetics Home Reference related topics:
Meier-Gorlin syndrome
isolated growth hormone deficiency
metatropic dysplasia
pseudoachondroplasia
Genetic and Rare Diseases Information Center resources:
Growth Hormone Deficiency
Isolated Growth Hormone Deficiency
Hypopituitarism
U.S. FDA Resources
Further study details as provided by University Hospital Inselspital, Berne:
Primary Outcome Measures:
- Flexibility of IMCaL, IMCL and IHCL (fat load and exercise) [ Time Frame: Year 1 to 4 ]
Secondary Outcome Measures:
- Determination of visceral fat mass by MRI [ Time Frame: Year 1 to 4 ]
- Determination of peripheral and hepatic insulin sensitivity by two step hyperinsulinemic euglycemic clamp [ Time Frame: Year 1 to 3 ]
- maximal exercise capacity [ Time Frame: Year 1 to 3 ]
| Estimated Enrollment: | 30 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | May 2015 |
| Estimated Primary Completion Date: | May 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
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1
Endurance trained athletes: minimal >50 mlO2/KG body weight
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2
Sedentary healthy control subjects: age, BMI, Gender and waist matched (to the growth hormone deficient patients)
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3
GHD patients without a GH substitution therapy in the last 6 months
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Dietary Supplement: Fat diet
Instructions for a high fat diet will be given at the end of visit 2. This consists of the usual food intake with a supplementary fat intake of 0.75g fat/kg BW, administered as 3 additional snacks. These snacks will be distributed in pre-packed bags. A food diary will be kept. All arms will receive this diet during the 3 days preceding the clamp.
Other: 2h standardized aerobic exercise
Aerobic (50-60% of Vo2 max) standardized exercise on a bicycle during 2 hours
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Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Athletes:Endurance trained athletes: minimal >50 mlO2/KG body weight
GH-deficient adult patients: NO GH-replacement therapy during the last 6 months
Sedentary controls: age, BMI, Gender and waist matched (to the growth hormone deficient patients) healthy control subjects
Criteria
Inclusion Criteria:
- Male and female patients >18 years old
- Capable to exercise for 120 minutes on a treadmill
- Willingness to participate in the study and to give written consent.
- Normal ECG during ergometry
- Specific for Athletes: VO2max> 50 ml/kg/min
- Specific for GHD patients: no GH substitution in the last 6 months
- Specific for sedentary controls: Matched the GHD patients for age, gender, BMI and waist
Exclusion Criteria
- Abnormal liver or renal function
- Active neoplasia
- Severe cardiovascular disease (unstable coronary artery disease, heart failure NYHA III-IV)
- Haemophilia
- Inability to exercise
- Contraindications to exposure to a 3 T magnetic field
- Abnormal ECG during ergometry
- Women in childbearing age unless on a continuous contraceptive therapy or surgically sterilized
- Depression, psychosis and other severe personality disorders
- Pregnant women
- Excessive alcohol consumption (>60g/d) or drug abuse
Contacts and Locations
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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: NCT01467193
Please refer to this study by its ClinicalTrials.gov identifier: NCT01467193
Locations
| Switzerland | |
| Department of Endocrinology, Diabetes and Clinical Nutrition, University Hospital Bern | Recruiting |
| Berne, Switzerland, 3010 | |
| Contact: Emanuel Christ, Prof., Dr med., MD; PhD +41 31 632 40 74 emanuel.christ@insel.ch | |
| Principal Investigator: Emanuel Christ, Prof., Dr med., MD; PhD | |
Sponsors and Collaborators
University Hospital Inselspital, Berne
Swiss National Science Foundation
Investigators
| Principal Investigator: | Emanuel Christ, Prof. Dr med. MD, PhD | Division of Endocrinology, Diabetes and Clinical Nutrition, University Hospital Bern |
More Information
Publications:
| Responsible Party: | Prof. Dr. med E. Christ, MD, PhD, Division of Endocrinology, Diabetes and Clinical Nutrition, Univeristy Hospital Bern |
| ClinicalTrials.gov Identifier: | NCT01467193 History of Changes |
| Other Study ID Numbers: |
234/10 |
| Study First Received: | November 3, 2011 |
| Last Updated: | September 8, 2014 |
Additional relevant MeSH terms:
|
Insulin Resistance Dwarfism, Pituitary Cardiac Complexes, Premature Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Dwarfism Bone Diseases, Developmental Bone Diseases Musculoskeletal Diseases Bone Diseases, Endocrine |
Hypopituitarism Pituitary Diseases Hypothalamic Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Endocrine System Diseases Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on June 22, 2017