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Low Fructose Diet in Diabetes Type 2

Primary Purpose

Fructose Metabolism Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
low frutose diet
Sponsored by
National Nutrition and Food Technology Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Fructose Metabolism Disorder

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age of 70-40 years
  2. body mass index(BMI) between 18.5 and 27
  3. Type 2 diabetes People who only control their diabetes by using glucose lowering tablets Type 2 diabetes (1 to 10 years)

Exclusion Criteria:

  1. Pregnancy and lactation
  2. Thyroid gland disorders
  3. Kidney disease and inflammation
  4. Follow the weight loss regimen 6 months before starting the study
  5. Usage of fatty and fatty foods, fiber powder Vitamin A Mineral Supplements, Omega 3
  6. Taking glucocorticoid drugs and non-steroidal anti-inflammatory drugs

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    intervention group

    control group

    Arm Description

    Eight weeks of low fructose diet with a maximum of 12 g of fructose

    Eight weeks of regular diabetic diet with a 15%pro 30%fat 55%CHO

    Outcomes

    Primary Outcome Measures

    fasting blood suger(FBS)
    Homeostatic model assessment and insulin resistance(HOMA-IR)
    insulin

    Secondary Outcome Measures

    Triglyceride
    Total cholestrole
    LDL-C
    HDL-C
    Blood pressure

    Full Information

    First Posted
    November 13, 2017
    Last Updated
    November 20, 2017
    Sponsor
    National Nutrition and Food Technology Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03352596
    Brief Title
    Low Fructose Diet in Diabetes Type 2
    Official Title
    Effects of Low Fructose Diet on Glycemic Control in Patients With Type 2 Diabetes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 1, 2017 (Actual)
    Primary Completion Date
    October 1, 2017 (Actual)
    Study Completion Date
    November 30, 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    National Nutrition and Food Technology Institute

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Diabetes is one of the most common and chronic diseases in the world, with the prevalence and incidence of this disease rising in most societies, especially in Iran. Suitable treatments for type 2 diabetes include changing lifestyle with exercise, nutrition, and drug use. New research suggests that added sugar, especially fructose, is the main trigger for diabetes and pre-diabetes even more potent than other carbohydrates. Fructose has a low glycemic index (23μg =) and slowly increases blood glucose levels. Therefore, it is thought that replacing fructose instead of glucose can have a positive effect on glycemic control of diabetic patients..

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fructose Metabolism Disorder

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    48 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    intervention group
    Arm Type
    Experimental
    Arm Description
    Eight weeks of low fructose diet with a maximum of 12 g of fructose
    Arm Title
    control group
    Arm Type
    No Intervention
    Arm Description
    Eight weeks of regular diabetic diet with a 15%pro 30%fat 55%CHO
    Intervention Type
    Other
    Intervention Name(s)
    low frutose diet
    Primary Outcome Measure Information:
    Title
    fasting blood suger(FBS)
    Time Frame
    8 weeks
    Title
    Homeostatic model assessment and insulin resistance(HOMA-IR)
    Time Frame
    8weeks
    Title
    insulin
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    Triglyceride
    Time Frame
    8 weeks
    Title
    Total cholestrole
    Time Frame
    8 weeks
    Title
    LDL-C
    Time Frame
    8 weeks
    Title
    HDL-C
    Time Frame
    8 weeks
    Title
    Blood pressure
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age of 70-40 years body mass index(BMI) between 18.5 and 27 Type 2 diabetes People who only control their diabetes by using glucose lowering tablets Type 2 diabetes (1 to 10 years) Exclusion Criteria: Pregnancy and lactation Thyroid gland disorders Kidney disease and inflammation Follow the weight loss regimen 6 months before starting the study Usage of fatty and fatty foods, fiber powder Vitamin A Mineral Supplements, Omega 3 Taking glucocorticoid drugs and non-steroidal anti-inflammatory drugs

    12. IPD Sharing Statement

    Learn more about this trial

    Low Fructose Diet in Diabetes Type 2

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