Obesity Clinical Trial
— FIDNLOfficial title:
Measure of Intestinal Lipogenesis in Healthy Volunteers and Obese Subjects Before and After Gastroplasty: Modulation by Glucose and Fructose
| NCT number | NCT01792089 |
| Other study ID # | 193/11 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | February 2013 |
| Est. completion date | December 2016 |
| Verified date | March 2019 |
| Source | University of Lausanne |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
8 healthy volunteers, 8 pre-bypass obese subjects, 8 subjects between 12-18 months
post-bypass, and 8 subjects matched to the post-bypass patients will be studied in two
sub-studies Sub-study 1) after ingestion of two or three different of the following
test-meals: A)cream and whey protein B)cream, whey protein and fructose + 13C6 fructose
C)test meal with cream, whey protein, fructose and glucose + 13C6 fructose Their intestinal
de novo lipogenesis will be estimated by measuring 13C-palmitate on triglyceride-rich
lipoprotein particles associated with apoB48 in blood Sub-study 2) after ingestion of two or
three different of the following test-meals: A)cream labelled with 13C6 palmitic acid and
whey protein B))cream labelled with 13C6 palmitic acid, whey protein, fructose and glucose
Their intestinal de novo lipogenesis will be estimated by measuring 13C-palmitate on
triglyceride-rich lipoprotein particles associated with apoB48 in blood in sub-study 1
Their exogenous lipid absorption kinetics will be assessed by measuring 13C palmitate on
triglyceride-rich lipoprotein particles associated with apoB48 in sub-study 2
| Status | Completed |
| Enrollment | 24 |
| Est. completion date | December 2016 |
| Est. primary completion date | December 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 25 Years to 50 Years |
| Eligibility |
Inclusion Criteria: - age 18-50 years - sex male or female - less than 2 kg body weight change over the past 3 months subjects Exclusion Criteria: - antidiabetic and hypolipemic drugs - alcohol consumption >20g/day - severe eating disorders - severe psychological problems - vegetarian diet or other specific diet - consumption of illicit substances - pregnancy - weight gain or weight loss > 1 kg in the last 3 months |
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | Centre Hospitalier Universitaire Vaudois | Lausanne | VD |
| Lead Sponsor | Collaborator |
|---|---|
| University of Lausanne |
Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Intestinal de novo lipogenesis (sub-study 1) | Measurement of total TG and 13C palmitate in chylomicrons: The sf >20 fraction of post-prandial blood samples will be prepared, and non-chylomicrons, apoB100-containing lipoprotein will be removes by immuno-affinity chromatography using a specific anti-apoB100 antibody | 0-8-hour post-prandial | |
| Primary | Postprandial exogenous, labelled palmitate concentration (sub-study 2) | Measurement of total TG and 13C palmitate in chylomicrons of sf >20 fraction of post-prandial blood samples will be prepared, | 0-8-hour post-prandial | |
| Secondary | post-prandial triglyceride profile (sub-studies 1 and 2 | Triglyceride will be measured in the chylomicron, VLDL, LDL and HDL fractions of post-prandial blood samples | 0-8 hour post-prandial |
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