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Curcumin Supplement in Nonalcoholic Fatty Liver Patients With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT02908152
Recruitment Status : Unknown
Verified September 2016 by Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute.
Recruitment status was:  Not yet recruiting
First Posted : September 20, 2016
Last Update Posted : September 20, 2016
Sponsor:
Information provided by (Responsible Party):
Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute

Brief Summary:
The purpose of this study is to investigate the effects of curcumin supplement on metabolic factors and hepatic fibrosis in nonalcoholic fatty liver patients with type 2 diabetes. Subjects will participate in 3 month, two group, randomized intervention, where one group (n=25) will take 1.5g/d curcumin and the other group (n=25) will take a placebo to compare differences in outcomes between the two groups.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Nonalcoholic Fatty Liver Dietary Supplement: curcumin Dietary Supplement: placebo Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Curcumin Supplement on Metabolic Factors and Hepatic Fibrosis in Nonalcoholic Fatty Liver Patients With Type 2 Diabetes
Study Start Date : February 2017
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : October 2017


Arm Intervention/treatment
Active Comparator: curcumin
curcumin
Dietary Supplement: curcumin

1500 mg

1 capsule / day for 12 weeks


Placebo Comparator: placebo Dietary Supplement: placebo

1500 mg

1 capsule / day for 12 weeks





Primary Outcome Measures :
  1. Hepatic steatosis [ Time Frame: [12 weeks] ]
    measured by CAP score using Fibroscan


Secondary Outcome Measures :
  1. Glucose [ Time Frame: [12 weeks] ]
  2. HBA1C [ Time Frame: [12 weeks] ]
  3. ALT [ Time Frame: [12 weeks] ]
  4. AST [ Time Frame: [12 weeks] ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient diagnosed with type 2 diabetes based on ADA definition or who only take oral antidiabetic drug;
  • CAP score >263.

Exclusion Criteria:

  • Taking any kind of antibiotics two weeks before recruitment;
  • History of alcohol consumption;
  • pregnancy or lactation;
  • Professional athletes;
  • Other liver disease (viral/etc);
  • High dose synthetic estrogens, methotrexate, amiodarone, steroids, chloroquine, immunosuppressive drugs;
  • A history of Cardiovascular disease;
  • Renal disease, Celiac disease, Cirrhosis;
  • History of Upper GI surgery;
  • A history of hypothyroidism or Cushing's syndrome;
  • History of drug dependence;
  • Body mass index (BMI) ≥35 kg/m2;
  • A restrictive diet or weight change ≥ 5 kg during the 3months prior to study;
  • Any change in treatment with oral hypoglycemic; anti hypertensive and antilipid agents during the study;
  • Use of weight loss medications.

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): NCT02908152


Locations
Iran, Islamic Republic of
Not yet recruiting
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
National Nutrition and Food Technology Institute

Responsible Party: Dr Azita Hekmatdoost, Principal Investigator, National Nutrition and Food Technology Institute
ClinicalTrials.gov Identifier: NCT02908152     History of Changes
Other Study ID Numbers: 467
First Posted: September 20, 2016    Key Record Dates
Last Update Posted: September 20, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Curcumin
Diabetes Mellitus
Diabetes Mellitus, Type 2
Fatty Liver
Non-alcoholic Fatty Liver Disease
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Liver Diseases
Digestive System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action