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Protein-rich Diet and NAFLD in Bariatric Surgery

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ClinicalTrials.gov Identifier: NCT02400099
Recruitment Status : Unknown
Verified March 2015 by Geltrude Mingrone, Catholic University of the Sacred Heart.
Recruitment status was:  Not yet recruiting
First Posted : March 26, 2015
Last Update Posted : March 26, 2015
Sponsor:
Collaborator:
Federico II University
Information provided by (Responsible Party):
Geltrude Mingrone, Catholic University of the Sacred Heart

Brief Summary:
Randomized, single-blind, trial to determine whether a high-protein, low calorie diet is more effective than a control low calorie diet in improving the metabolic and histologic abnormalities in patients with Non-alcoholic Fatty Liver Disease undergoing bariatric surgery.

Condition or disease Intervention/treatment Phase
Obesity Non-alcoholic Fatty Liver Disease Dietary Supplement: High-protein low calorie diet Dietary Supplement: Control low calorie diet Other: Anthropometrical measurements Other: Body composition Other: 8-h metabolic profile Other: Liver biopsy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Protein-rich Diet and Non-Alcoholic Fatty Liver Disease in Bariatric Surgery
Study Start Date : June 2015
Estimated Primary Completion Date : June 2016


Arm Intervention/treatment
Active Comparator: High-protein low calorie diet (HPLC)
900 Kcal; Protein 90 g (39%); CHO 75 g (30%); Lipid 32 g (31%)
Dietary Supplement: High-protein low calorie diet
Other: Anthropometrical measurements
Other: Body composition
Other: 8-h metabolic profile
Other: Liver biopsy
Placebo Comparator: Control low calorie diet (CLC)
900 Kcal; Protein. 50 g (22%); CHO 119 g (48%); Lipid 31 g (30%)
Dietary Supplement: Control low calorie diet
Other: Anthropometrical measurements
Other: Body composition
Other: 8-h metabolic profile
Other: Liver biopsy



Primary Outcome Measures :
  1. Liver fat content assessment [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Insulin sensitivity assessment [ Time Frame: 1 year ]
  2. fat free mass assessment [ Time Frame: 1 year ]


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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Morbidly obese subjects with a BMI >40 kg/m2 who are eligible for bariatric surgery and have accepted to undergo RYGB
  • Weight stable for at least 6 months before the study (+/- 5 kg within the previous 6 months)
  • Stable medication
  • Provision of informed consent

Exclusion Criteria:

  • Patients not eligible for laparoscopic RYGB
  • Incapacity to give a valid informed consent or unwilling to give the consent
  • Pregnancy or lactating
  • Type 2-diabetes mellitus
  • Significant illness within the two weeks preceding surgery, as judged by the physician.
  • Obvious infection (bacteria, virus etc)
  • Major cardiovascular disease
  • Major gastrointestinal, respiratory, or any hormonal disorders
  • History of drug addiction and/or alcohol use
  • Suspected or confirmed poor compliance
  • Alcohol consumption of > 20 g per day in the case of women and > 30 g per day in the case of men for at least 3 consecutive months during the previous 5 years
  • Presence of hepatitis C or frank cirrhosis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02400099


Contacts
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Contact: Geltrude Mingrone, Professor 0630154395 ext 0039 gmingrone@rm.unicatt.it

Locations
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Italy
Catholic University School of Medicine
Rome, Italy, 00168
Sponsors and Collaborators
Catholic University of the Sacred Heart
Federico II University

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Responsible Party: Geltrude Mingrone, Associate Professor, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT02400099     History of Changes
Other Study ID Numbers: UCSC-2015
First Posted: March 26, 2015    Key Record Dates
Last Update Posted: March 26, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases