Insulin Sensitivity Clinical Trial
Official title:
Determinants of Liver Fat Composition in Overweight and Obese Humans
NCT number | NCT03211299 |
Other study ID # | NL60263.068.16 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 15, 2017 |
Est. completion date | May 17, 2018 |
Verified date | June 2018 |
Source | Maastricht University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Excessive fat in the liver, in absence of high alcohol consumption, is diagnosed as non-alcoholic fatty liver (NAFL). NAFL prevalence is as high as 50-70% in obese people and is associated with impairments in metabolic health, e.g. insulin resistance. Not only the amount, but also the composition of the fat stored in the liver appears to be linked to health outcome measures, such as insulin resistance, but this evidence comes mainly from animal studies. Since fat composition has been linked to health outcome measures, it is important to understand what determines the fatty acid composition of liver fat. De novo lipogenesis (DNL) and adipose tissue fat composition are factors that could determine liver fat composition. Since the end product of DNL are saturated fatty acids and as the majority of fatty acids in the liver originate from adipose tissue, both may influence hepatic fatty acid composition profoundly. Here, our primary hypothesis is that DNL is associated with the relative amount of saturated fatty acids in the liver in overweight/obese humans differing in liver fat content. Furthermore, we hypothesise that adipose tissue fat composition is associated with liver fat composition and that liver fat composition is associated with liver, muscle and whole body insulin sensitivity in overweight/obese humans differing in liver fat content. To this end, liver fat composition, adipose tissue fat composition, DNL and insulin sensitivity will be measured in overweight/obese participants differing in liver content.
Status | Completed |
Enrollment | 19 |
Est. completion date | May 17, 2018 |
Est. primary completion date | May 5, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 45 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Signed informed consent - Caucasian (people will be excluded when having a 50% or a more then 50% racial African/Asian background) - Male or postmenopausal female - Aged 45-70 years at start of the study - Body mass index (BMI) 27 - 35 kg/m2 - Stable dietary habits (no weight loss or gain >3kg in the past 3 months) - Sedentary lifestyle (not more than 2 hours of sports per week) Exclusion Criteria: - Type 2 diabetes - Active diseases (cardiovascular, diabetes, liver, kidney, cancer or other) - Contra-indication for MRI (which can be found in appendix I) - Alcohol consumption of >2 servings per day - Smoking >5 cigarettes per day - Use of anti-coagulants |
Country | Name | City | State |
---|---|---|---|
Netherlands | Maastricht University Medical Center | Maastricht | Limburg |
Lead Sponsor | Collaborator |
---|---|
Maastricht University Medical Center | Unilever R&D |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Intrahepatic fat accumulation | expressed as % (determined by magnetic resonance spectroscopy) | 10 minutes | |
Other | body composition | expressed as fat mass (%) and fat-free mass (%) (determined by BodPod) | 15 minutes | |
Other | abdominal visceral adipose tissue and abdominal subcutaneous adipose tissue | expressed as % (determined by magnetic resonance spectroscopy) | 10 minutes | |
Primary | %SFA in the liver | expressed as relative amount of SFA to the total amount of fatty acids (determined by magnetic resonance spectroscopy) | 20 minutes | |
Primary | DNL | expressed as percentage of palmitate in VLDL-TG originating from DNL (determined by use of deuterium water) | 16 hours | |
Secondary | Liver fat composition | expressed as relative amount of MUFA and PUFA to the total amount of fatty acids, in addition to %SFA (determined by magnetic resonance spectroscopy) | 20 minutes | |
Secondary | Adipose tissue fat composition | expressed as relative amount of SFA, MUFA and PUFA to the total amount of fatty acids (determined by magnetic resonance spectroscopy and from subcutaneous adipose tissue biopsy) | 20 minutes | |
Secondary | Adipose tissue fat composition | expressed as relative amount of linoleic acid, docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) to the total amount of fatty acids (determined from subcutaneous adipose tissue biopsy) | 15 minutes | |
Secondary | Hepatic insulin sensitivity | expressed as % suppression of endogenous glucose production (EGP)(determined by hyperinsulinemic euglycemic clamp). | 8.5 hours | |
Secondary | Muscle insulin sensitivity | expressed as determinants/markers for muscle insulin sensitivity in muscle biopsy (oxphos, GLUT4, intramyocellular lipids (IMCL). | 15 minutes | |
Secondary | peripheral insulin sensitivity | expressed as rate of disappearance (Rd) in µmol/kg/min (determined by hyperinsulinemic euglycemic clamp). | 8.5 hours | |
Secondary | whole body insulin sensitivity | expressed as glucose infusion rate (GIR) in µmol/kg/min (determined by hyperinsulinemic euglycemic clamp). | 8.5 hours |
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