The Effect of Dietary Fat Load and Physical Exercise on the Flexibility and Partioning of Ectopic Lipids.
This study is enrolling participants by invitation only.
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: NA
Last verified: November 2011
History: No changes posted
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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 partioning 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 partioning 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 Partioning of Ectopic Lipids. |
Resource links provided by NLM:
Genetics Home Reference related topics:
combined pituitary hormone deficiency
isolated growth hormone deficiency
metatropic dysplasia
pseudoachondroplasia
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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Determination of visceral fat mass by MRI [ Time Frame: Year 1 to 4 ] [ Designated as safety issue: No ]
- Determination of peripheral and hepatic insulin sensitivity by two step hyperinsulinemic euglycemic clamp [ Time Frame: Year 1 to 3 ] [ Designated as safety issue: No ]
- maximal exercise capacity [ Time Frame: Year 1 to 3 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1
Endurance trained athletes: minimal >50 mlO2/KG body weight
|
|
|
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
|
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
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01467193
Locations
| Switzerland | |
| Department of Endocrinology, Diabetes and Clinical Nutrition, University Hospital Bern | |
| Berne, Switzerland, 3010 | |
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: | November 3, 2011 |
| Health Authority: | Switzerland: Independent Local Research Ethic Commission (Ethikkommission) |
Additional relevant MeSH terms:
|
Dwarfism, Pituitary Cardiac Complexes, Premature Endocrine System Diseases Insulin Resistance 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 Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013