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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University Hospital Inselspital, Berne
Sponsor:
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
History of Changes
  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)

  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 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:

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: May 2015
Estimated Primary Completion Date: May 2015 (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)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

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
Health Authority: Switzerland: Ethikkommission

Additional relevant MeSH terms:
Dwarfism, Pituitary
Bone Diseases
Bone Diseases, Developmental
Bone Diseases, Endocrine
Brain Diseases
Central Nervous System Diseases
Dwarfism
 Endocrine System Diseases
Hypopituitarism
Hypothalamic Diseases
Musculoskeletal Diseases
Nervous System Diseases
Pituitary Diseases

ClinicalTrials.gov processed this record on March 03, 2015