Impact of Bariatric Surgery on Nonalcoholic Fatty Liver Disease in Diabetic Patients

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2013 by Sheba Medical Center
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01828528
First received: April 3, 2013
Last updated: April 7, 2013
Last verified: April 2013
  Purpose

The purpose of this study is to investigate the effect of weight loss rate on liver steatosis, steatohepatitis and fibrosis at different stages before and after bariatric surgery. In addition, the investigators would like to study the effect of low carbohydrate diet given for a month before bariatric surgery on liver steatosis. The investigators also aim to study the short-term effect of bariatric surgery on gastric cholecystokinin levels before and 10 days after the bariatric surgery.


Condition Intervention
Nonalcoholic Fatty Liver Disease (NAFLD).
Nonalcoholic Steatohepatitis.
Diabetes.
Procedure: Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG).
Other: Low carbohydrate diet

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Impact of Bariatric Surgery on Nonalcoholic Fatty Liver Disease in Diabetic Patients: Pre- and Post-Surgical Evaluation Utilizing Non-invasive Measures

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Change from baseline liver steatosis, steatohepatitis and fibrosis at different stages after bariatric surgery, measured by non-invasive measurements as described below. [ Time Frame: Baseline is defined as three weeks to one month before surgery. Different stages to compare to baseline are as following: 8-12 days and 6, 12, 24 and 48 weeks after surgery. ] [ Designated as safety issue: No ]

    Measurements to be performed to assess liver disease stage at baseline and at 8-12 days and 6, 12, 24 and 48 weeks after surgery:

    1. Blood tests of liver functions (Alanine transaminase, Aspartate transaminase, Alkaline Phosphatase, gamma-glutamyl transpeptidase, ferritin, prothrombin-time (PT), international normalized ratio (INR), Total/Direct Bilirubin, Albumin, uric acid), lipids profile (total cholesterol, triglycerides, HDL, LDL) and diabetes biomarkers (insulin, glucose, HbA1c).
    2. Blood tests of adiponectin and tumor necrosis factor (only at baseline and at 12, 24 and 48 weeks after surgery).
    3. Fibroscan test for quantifying liver fibrosis by means of elastography (only at baseline and at 24 and 48 weeks after surgery).
    4. A blood test (FibroMax) for determining the stage and grade of liver damage (only at baseline and at 12, 24 and 48 weeks after surgery).


Secondary Outcome Measures:
  • Change of liver steatosis following a low carbohydrates diet at time of surgery compared to baseline. [ Time Frame: Baseline is defined as three weeks to one month before surgery. Change will be assessed 1-2 days before surgery. ] [ Designated as safety issue: No ]

    A low carbohydrates diet will be given for 3 weeks to a month prior surgery day.

    Change will be assessed by the following measurements 3 weeks to a month before surgery and at 1-2 days before surgery:

    1. Blood tests of liver functions (Alanine transaminase, Aspartate transaminase, Alkaline Phosphatase, gamma-glutamyl transpeptidase, ferritin, PT, INR, Total/Direct Bilirubin, Albumin, uric acid), lipids profile (total cholesterol, triglycerides, HDL, LDL) and diabetes biomarkers (glucose, HbA1c).
    2. A blood test for determining the stage and grade of liver damage (FibroMax).
    3. An intraoperative liver biopsy (on surgery day only).

  • Change in cholecystokinin levels before and after the surgery. [ Time Frame: Baseline levels of cholecystokinin at 1-2 days before surgery compared to 8-12 days after surgery. ] [ Designated as safety issue: No ]
    In addition, gastric cholecystokinin levels will be measured from the removed stomach tissue.


Biospecimen Retention:   Samples With DNA

Whole blood, Liver tissue


Estimated Enrollment: 30
Study Start Date: April 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
RYGB/SG Diabetic NAFLD
30 diabetic patients with NAFLD undergoing Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG) and a low carbohydrates diet before surgery.
Procedure: Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG).
Surgery includes intraoperative Tru-Cut liver biopsy.
Other: Low carbohydrate diet
Low carbohydrates diet, starting 3 weeks before surgery, providing daily amount of: 60g Carbohydrates, 1400 Kilo-Calories and 130g protein.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

30 diabetic patients with NAFLD (diagnosed by ultra sound) undergoing Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG) at Surgery C department at Sheba Medical Center, Israel.

Criteria

Inclusion Criteria:

  • 20≤ age ≤80
  • BMI>35kg/m2
  • Men and women
  • Fatty infiltration in liver ultrasonography > 30%
  • Diagnosed diabetes according to:

    1. HbA1c≥6.8% or
    2. Fasting plasma glucose (PG) ≥126mg/dl or
    3. 2 hours PG ≥ 200mg/dl during 75gr Oral glucose tolerance test, or
    4. random PG≥200mg/dl and hyperglycemic symptoms)

Exclusion Criteria:

  • Alcohol drinking > 140g/week
  • Presence of hepatitis B or C or HIV
  • Known liver disease such as:

    1. Wilson's disease
    2. hemochromatosis
    3. α1-antitrypsin deficiency
    4. autoimmune liver disease
    5. primary biliary cirrhosis
    6. primary sclerosing cholangitis)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01828528

Contacts
Contact: Carmit Netanel +97235307185 carmit.netanel@sheba.health.gov.il
Contact: Avishag Hassid +97235307180 avishag.hassid@sheba.health.gov.il

Locations
Israel
Liver Disease Center, Sheba Medical Center, Tel-Hashomer
Ramat-Gan, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Ziv Ben-Ari, Prof Director Liver Disease Center, Sheba Medical Center, Tel-Hashomer, Israel
  More Information

No publications provided

Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01828528     History of Changes
Other Study ID Numbers: SHEBA-12-0026-ZB-CTIL
Study First Received: April 3, 2013
Last Updated: April 7, 2013
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
Nonalcoholic fatty liver disease
Nonalcoholic steatohepatitis
Obesity
Bariatric surgery
Weight loss

Additional relevant MeSH terms:
Liver Diseases
Fatty Liver
Digestive System Diseases

ClinicalTrials.gov processed this record on September 18, 2014