The Effect of Dietary Fat Load and Physical Exercise on the Flexibility and Partitioning of Ectopic Lipids.
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| ClinicalTrials.gov Identifier: NCT01467193 |
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Recruitment Status : Unknown
Verified September 2014 by University Hospital Inselspital, Berne.
Recruitment status was: Recruiting
First Posted : November 8, 2011
Last Update Posted : September 9, 2014
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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 or disease | Intervention/treatment |
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| Ectopic Lipids Insulin Sensitivity Aerobic Exercise Fat Load Growth Hormone Deficiency | Dietary Supplement: Fat diet Other: 2h standardized aerobic exercise |
Show Detailed Description
| Study Type : | Observational |
| Estimated Enrollment : | 30 participants |
| 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. |
| Study Start Date : | August 2011 |
| Estimated Primary Completion Date : | May 2015 |
| Estimated Study Completion Date : | May 2015 |
| Group/Cohort | Intervention/treatment |
|---|---|
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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 |
- Flexibility of IMCaL, IMCL and IHCL (fat load and exercise) [ Time Frame: Year 1 to 4 ]
- 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 ]
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01467193
| 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 | |
| Principal Investigator: | Emanuel Christ, Prof. Dr med. MD, PhD | Division of Endocrinology, Diabetes and Clinical Nutrition, University Hospital Bern |
Publications of Results:
| 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 |
| First Posted: | November 8, 2011 Key Record Dates |
| Last Update Posted: | September 9, 2014 |
| Last Verified: | September 2014 |
Additional relevant MeSH terms:
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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 |