The Effect of Dietary Fat Load and Physical Exercise on the Flexibility and Partitioning of Ectopic Lipids.

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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)

1. Ectopic fats stores are flexible fuel stores and are influenced by diet and physical activity.FFA availability may play an important regulatory role.
2. There is a tissue specific partitioning of triglycerides and/or FFA among non-adipose organs after fat load and physical exercise
3. The flexibility of ectopic fat stores is related to insulin sensitivity
4. 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.
5. 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
6. A short intensive physical exercise shows a good discriminative power to diagnose GHD.

Condition or disease	Intervention/treatment
Ectopic Lipids; Insulin Sensitivity; Aerobic Exercise; Fat Load; Growth Hormone Deficiency	Dietary Supplement: Fat diet; Other: 2h standardized aerobic exercise

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Study Design

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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

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort	Intervention/treatment
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)
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

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Flexibility of IMCaL, IMCL and IHCL (fat load and exercise) [ Time Frame: Year 1 to 4 ]

Secondary Outcome Measures :

1. Determination of visceral fat mass by MRI [ Time Frame: Year 1 to 4 ]
2. Determination of peripheral and hepatic insulin sensitivity by two step hyperinsulinemic euglycemic clamp [ Time Frame: Year 1 to 3 ]
3. maximal exercise capacity [ Time Frame: Year 1 to 3 ]

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Zueger T, Alleman S, Christ ER, Stettler C. Exercise-induced GH secretion in the assessment of GH deficiency in adult individuals. Eur J Endocrinol. 2011 Nov;165(5):723-8. doi: 10.1530/EJE-11-0539. Epub 2011 Aug 19.

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
Last Update Posted:	September 9, 2014
Last Verified:	September 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