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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01467193
• Date of registration: 03/11/2011
• Prospective Registration: No
• Primary sponsor: University Hospital Inselspital, Berne
• Public title: The Effect of Dietary Fat Load and Physical Exercise on the Flexibility and Partitioning of Ectopic Lipids.
• Scientific title: The Effect of Dietary Fat Load and Physical Exercise on the Flexibility and Partitioning of Ectopic Lipids.
• Date of first enrolment: August 2011
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01467193
• Study type: Observational

Countries of recruitment

Switzerland

Contacts

• Name: Emanuel Christ, Prof. Dr med. MD, PhD
• Affiliation: Division of Endocrinology, Diabetes and Clinical Nutrition, University Hospital Bern

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Aerobic Exercise

Insulin Sensitivity

Ectopic Lipids

Fat Load

Growth Hormone Deficiency

Intervention(s)

Dietary Supplement: Fat diet

Other: 2h standardized aerobic exercise

Primary Outcome(s)

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

Secondary Outcome(s)

Determination of visceral fat mass by MRI [Time Frame: Year 1 to 4]

maximal exercise capacity [Time Frame: Year 1 to 3]

Determination of peripheral and hepatic insulin sensitivity by two step hyperinsulinemic euglycemic clamp [Time Frame: Year 1 to 3]

Secondary ID(s)

234/10

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Swiss National Science Foundation