Lipid Metabolism Disorder Clinical Trial
— AGL9Official title:
The Relative Contribution of Dietary Lipids vs. of Fatty Acids to Non-adipose Tissues and the Effect of a Carbohydrate-rich Diet in Healthy Subjects
Verified date | September 2019 |
Source | Université de Sherbrooke |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The present research protocol will analyze whether a short-term modification (one week) of
dietary habits would have an impact on the postprandial metabolism of dietary fatty acids and
on their uptake by non-adipose tissues, in healthy subjects.
Each subject will participate in two protocols randomly determined and separated by a period
of one month: a 7-day isocaloric diet (Protocol A) and a 7-day carbohydrate-rich diet
containing +50% of the subject's energy needs. (Protocol B).
At the end of each diet, the subject will go through a postprandial metabolic study of 8
hours where different parameters will be measured thanks to PET imaging and perfusions of
stables isotopes.
Status | Completed |
Enrollment | 14 |
Est. completion date | July 2, 2019 |
Est. primary completion date | March 20, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: Healthy subjects: subjects with normal glucose tolerance determined according to an oral glucose tolerance test and with a BMI above 25 kg/m2 without first degree of familial history of type 2 diabetes (parents, siblings). Exclusion Criteria: - overt cardiovascular disease as assessed by medical history, physical exam, and abnormal ECG - treatment with a fibrate, thiazolidinedione, beta-blocker or other drug known to affect lipid or carbohydrate metabolism (except statins, metformin, and other antihypertensive agents that can be safely interrupted) - presence of liver or renal disease, uncontrolled thyroid disorder, previous pancreatitis, bleeding disorder, or other major illness - smoking (>1 cigarette/day) and/or consumption of >2 alcoholic beverages per day - prior history or current fasting plasma cholesterol level > 7 mmol/l or fasting TG > 5 mmol/l - any other contraindication to temporarily interrupt current meds for lipids or hypertension - being pregnant - not be barren |
Country | Name | City | State |
---|---|---|---|
Canada | Centre de recherche du CHUS | Sherbrooke | Quebec |
Lead Sponsor | Collaborator |
---|---|
Université de Sherbrooke | Hospices Civils de Lyon |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | whole-body organ-specific Dietary Fatty Acid (DFA) partitioning | will be determined by whole-body CT (16 mA) followed by PET acquisition of 18FTHA | 2 months | |
Primary | Left ventricular function by Positron Emiting Positron (PET) ventriculography | will be determined using 11C-acetate PET/CT. 180 MBq will be administered by bolus injection at fasting. After a transmission scan and regional CT (40mA), a 30-min dynamic list-mode PET acquisition will be performed on a 18 cm-high thoraco-abdominal segment to include the left cardiac ventricle and most of the liver on a Philips Gemini TOF PET/CT | 2 months | |
Secondary | Cardiac DFA uptake | will be assessed using PET/CT method with oral administration of 18FTHA followed by a 30 min. dynamic PET acquisition | 2 months | |
Secondary | Cardiac and hepatic oxidative metabolism index | will be determined using 11C-acetate PET/CT followed by a 30 minutes dynamic PET acquisition. | 2 months | |
Secondary | Cardiac and hepatic blood flow | will be determined using 11C-acetate PET/CT followed by a 30 minutes dynamic PET acquisition.. | 2 months | |
Secondary | metabolites appearance rate | will be determined by perfusion of stable isotope tracers | 6 months | |
Secondary | energy metabolism (whole body production) | by indirect calorimetry | 4 months | |
Secondary | hormonal responses | analysed by colorimetric and Elisa tests | 4 months | |
Secondary | Insulin sensitivity | will be determined using the HOMA-IR (based on fasting insulin and glucose) levels | 4 months | |
Secondary | Insulin secretion rate | will be assessed using deconvolution of plasma C-peptide with standard Cpeptide kinetic parameters | 4 months | |
Secondary | ß-cell function | will be assessed by calculation of the disposition index (DI) that is insulin secretion in response to the ambient insulin | 4 months | |
Secondary | Anthropometric parameters | will be measured at each postprandial metabolic study | 2 months |
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