No significant disease other than obesity/type 2 diabetes/hypertension/NAFLD
Conditions
Interventions
Trade Name: Actrapid
Product Name: Actrapid
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INSULIN HUMAN
CAS Number: 11061-68-0
Concentration unit: IU international unit(s)
Concentra
Sponsors
Helsinki University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A | — |
Countries
Finland
Contacts
Public ContactUniversity of Helsinki
University of Helsinki
Outcome results
None listed