SIGNAL TRANSDUCTION IN NAFLD
- Conditions
- o significant disease other than obesity/type 2 diabetes/hypertension/NAFLDTherapeutic area: Body processes [G] - Metabolic Phenomena [G03]
- Registration Number
- EUCTR2013-003791-12-FI
- Lead Sponsor
- Helsinki University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Study subjects (10 NAFLD and 10 non-NAFLD for each time point, the fasting samples already exist) will be morbidly obese patients who are eligible for gastric banding-, gastric by-pass or sleeve gastrectomy operation for a treatment of obesity. The liver biopsy will be taken if clinically considered indicated by the surgeon for diagnosis of NASH.
The following inclusion/ exclusion criteria will be employed:
1. Subjects must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.
2. Age range from 18 to 65 years.
3. Alcohol consumption less than 20 g/day as assessed by a questionnaire.
4. Seronegative for hepatitis B and C.
5. Lack of significant other liver disease as determined by hepatic ultrasound and Fibroscan preoperatively.
6. No insulin, injectable GLP-1 –analogue or TZD treatment if type 2 diabetes.
7. No significant disease other than obesity/type 2 diabetes/hypertension/NAFLD as determined by history and physical examination and laboratory tests.
8. Use of drugs such as corticosteroids which could affect glucose metabolism.
9. Pregnancy as determined by a pregnancy test in women of child-bearing potential.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Study subjects (10 NAFLD and 10 non-NAFLD for each time point, the fasting samples already exist) will be morbidly obese patients who are eligible for gastric banding-, gastric by-pass or sleeve gastrectomy operation for a treatment of obesity. The liver biopsy will be taken if clinically considered indicated by the surgeon for diagnosis of NASH.
The following inclusion/ exclusion criteria will be employed:
1. Subjects must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.
2. Age range from 18 to 65 years.
3. Alcohol consumption less than 20 g/day as assessed by a questionnaire.
4. Seronegative for hepatitis B and C.
5. Lack of significant other liver disease as determined by hepatic ultrasound and Fibroscan preoperatively.
6. No insulin, injectable GLP-1 –analogue or TZD treatment if type 2 diabetes.
7. No significant disease other than obesity/type 2 diabetes/hypertension/NAFLD as determined by history and physical examination and laboratory tests.
8. Use of drugs such as corticosteroids which could affect glucose metabolism.
9. Pregnancy as determined by a pregnancy test in women of child-bearing potential.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine how signal transduction differs between patients with NAFLD vs. those without.;Secondary Objective: To determine how signal transduction differs between patients with NAFLD vs. those without.;Primary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A
- Secondary Outcome Measures
Name Time Method Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A