Insulin Sensitivity Clinical Trial
Official title:
The Effect of Dietary Fat Load and Physical Exercise on the Flexibility and Partitioning of Ectopic Lipids.
NCT number | NCT01467193 |
Other study ID # | 234/10 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 2011 |
Est. completion date | May 2014 |
Verified date | October 2018 |
Source | University Hospital Inselspital, Berne |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | May 2014 |
Est. primary completion date | May 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Department of Endocrinology, Diabetes and Clinical Nutrition, University Hospital Bern | Berne |
Lead Sponsor | Collaborator |
---|---|
University Hospital Inselspital, Berne | Swiss National Science Foundation |
Switzerland,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Flexibility of IMCaL, IMCL and IHCL (fat load and exercise) | Year 1 to 4 | ||
Secondary | Determination of visceral fat mass by MRI | Year 1 to 4 | ||
Secondary | Determination of peripheral and hepatic insulin sensitivity by two step hyperinsulinemic euglycemic clamp | Year 1 to 3 | ||
Secondary | maximal exercise capacity | Year 1 to 3 |
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