Hypertriglyceridemia Clinical Trial
Official title:
Fructose Consumption Aggravates Dysregulation of Postprandial Lipid Metabolism in Obese Hypertriglyceridemic Men With High Cardiometabolic Risk Profile and Associates With Liver Fat Deposition
NCT number | NCT01445730 |
Other study ID # | T1010K0029 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 2011 |
Est. completion date | June 2015 |
Verified date | May 2021 |
Source | Helsinki University Central Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
High fructose intake is increasingly recognized as causative in development of prediabetes, metabolic syndrome and cardiovascular disease (CVD). The mechanisms underlying fructose-induced metabolic disturbances are unclear but are beginning to be unraveled. In contrast to metabolism of glucose, the breakdown of fructose leads to the generation of metabolites that stimulate hepatic de novo lipogenesis (DNL) and increased levels of both fasting and postprandial triglycerides. The key lipogenic transcription factor seems to be activated by fructose independently of insulin. However, it is still controversial whether fructose consumption increases DNL in man to the extent that it induces metabolic disturbances. Animal studies have shown that also the adipose tissue is responsive to fructose feeding fructose, and that high fructose-feeding induces insulin resistance and inflammation in the adipose tissue. The role of intestinal insulin resistance in fructose-induced dysmetabolism has not been studied in detail. The critical question is whether the metabolic disturbances are induced by calorie excess or by fructose per se.
Status | Completed |
Enrollment | 82 |
Est. completion date | June 2015 |
Est. primary completion date | May 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 20 Years to 60 Years |
Eligibility | Inclusion Criteria: - Body mass index 27-40 - Waist > 96 cm - Age 20-60 years - Male Exclusion Criteria: - Smoking - Active health problems - Contraindications to MRI scanning - Bleeding tendency - Abnormal liver or renal function tests - Type 2 diabetes - Evidence of metabolic or viral liver disease - Alcohol intake > 21 units per week - Chronic medication except ones needed for stable hypertension |
Country | Name | City | State |
---|---|---|---|
Canada | Université Laval | Québec | |
Finland | Helsinki University Central Hospital, Biomedicum | Helsinki | |
Italy | University of Naples, Federico II, and Faculty of Medicine | Naples | |
Sweden | Sahlgrenska Academy at University of Gothenburg and Sahlgrenska University Hospital | Gothenburg |
Lead Sponsor | Collaborator |
---|---|
Marja-Riitta Taskinen | Laval University, Lund University, Sahlgrenska University Hospital, Sweden, University of Naples |
Canada, Finland, Italy, Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | TG Plasma AUC | Before vs. after fructose challenge: Triglycerides (TG) plasma Area Under Curve (AUC) | Form the baseline (time point 1) to end of treatment at 3 months (time point 2) | |
Primary | B48 Plasma AUC | Before vs. after fructose challenge: apolipoprotein (apo)B48 plasma Area Under Curve (AUC) | Form the baseline (time point 1) to end of treatment at 3 months (time point 2) | |
Primary | TG Plasma iAUC | Before vs. after fructose challenge:Triglycerides (TG) plasma incremental Area Under Curve (iAUC) | Form the baseline (time point 1) to end of treatment at 3 months (time point 2) | |
Secondary | DNL | Before vs. after fructose challenge: de novo lipogenesis (DNL) | Form the baseline (time point 1) to end of treatment at 3 months (time point 2) | |
Secondary | ApoC-III | Before vs. after fructose challenge: Apolipoprotein C-III (ApoC-III) | Form the baseline (time point 1) to end of treatment at 3 months (time point 2) | |
Secondary | ß-OH Butyrate | Before vs. after fructose challenge: beta-OH butyrate (ß-OH butyrate) | Form the baseline (time point 1) to end of treatment at 3 months (time point 2) | |
Secondary | Liver Fat | Before vs. after fructose challenge | Form the baseline (time point 1) to end of treatment at 3 months (time point 2) |
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