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Effectiveness of Nutritional Program Among Diabetic Patients

Primary Purpose

Dyslipidemia Associated With Type II Diabetes Mellitus

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
DASH diet
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemia Associated With Type II Diabetes Mellitus

Eligibility Criteria

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

Inclusion Criteria:

  • 1-clinical diagosis of type2diabetes 2-clinical diagnosis of hyperlpidemia 3-must be helpful patient 4-age below 70year

Exclusion Criteria:

1-insulin dependant diabetes 2- pregnancy 3-heart disease 4- renal disease. 5-pregnancy

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    group of intervention will receive nutritional program

    group of control will not receive nutritional program

    Arm Description

    group of type 2 diabetes on diabetic diet undergo nutritional program (low fat contents) to control the lipid profile (lowering cholesterol profile) in duration of 3 months.

    group of type 2 diabetes on diabetic drugs without nutritional program to compare their lipid profile with the diabetic patients on nutritional program.

    Outcomes

    Primary Outcome Measures

    Evaluate the effectiveness of one of the most common dietary approches;DASH diet in controlling lipid profile in diabetic patients.
    number of type 2 diabetic patients will undergo nutritional program to control their lipid profile to improve the insulin sensitivity and follow up the result of the diet by investigations (lipid profile) in duration 3 months .

    Secondary Outcome Measures

    Full Information

    First Posted
    September 15, 2021
    Last Updated
    November 17, 2021
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05128747
    Brief Title
    Effectiveness of Nutritional Program Among Diabetic Patients
    Official Title
    Effectiveness of Nutritional Program Intervention for Control of Lipid Profile Among Diabetic Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 1, 2022 (Anticipated)
    Primary Completion Date
    October 1, 2022 (Anticipated)
    Study Completion Date
    December 30, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    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
    Dyslipidemia is very common in type 2 diabetes mellitus affecting around 72%-85% of diabetic patients.The exact mechanism of lipoprotein abnormalities in diabetes is not very well understood. Insulin resistance, rather than hyperglycemia, has been implicated in the pathogenesis of diabetic dyslipidemia because lipoprotein changes including an increase in triglycerides (TG), increase in VLDL particles, small dense LDL particles and a decrease in HDL level have been shown in patients with impaired fasting glucose and impaired glucose tolerance and T2DM
    Detailed Description
    Hypertriglyceridaemia(HTG) occurs due to both increased production and decreased clearance, and it is the most common abnormality of diabetic dyslipidemia. Insulin resistance causes increased production of VLDL . In addition to increased secretion of VLDL, there is decreased clearance of VLDL due to decreased hepatic uptake and impaired activity of lipoprotein lipase.Management of dyslipidemia in patients with diabetes is an important step in the prevention of cardiovascular disease, the most common cause of death in the diabetic population. Diabetic dyslipidemia treatments can be divided into non-pharmacological and pharmacological. Non-pharmacological treatment includes ; medical nutrition therapy, weight loss, and physical activity. Diabetic patients should increase the intake of plant stanols/sterols, viscous fiber (legumes, citrus, oats), n-3 fatty acids and decrease the intake of saturated and trans-fatty acids. American Diabetes Association recommends the Mediterranean diet or DASH (Dietary Approaches to Stop Hypertension).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dyslipidemia Associated With Type II Diabetes Mellitus

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    diabetic patients type2 with dyslipidemia
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    190 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    group of intervention will receive nutritional program
    Arm Type
    Active Comparator
    Arm Description
    group of type 2 diabetes on diabetic diet undergo nutritional program (low fat contents) to control the lipid profile (lowering cholesterol profile) in duration of 3 months.
    Arm Title
    group of control will not receive nutritional program
    Arm Type
    No Intervention
    Arm Description
    group of type 2 diabetes on diabetic drugs without nutritional program to compare their lipid profile with the diabetic patients on nutritional program.
    Intervention Type
    Other
    Intervention Name(s)
    DASH diet
    Intervention Description
    it will be face to face about the role of nutritional program to control dyslipidemia
    Primary Outcome Measure Information:
    Title
    Evaluate the effectiveness of one of the most common dietary approches;DASH diet in controlling lipid profile in diabetic patients.
    Description
    number of type 2 diabetic patients will undergo nutritional program to control their lipid profile to improve the insulin sensitivity and follow up the result of the diet by investigations (lipid profile) in duration 3 months .
    Time Frame
    3-6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 1-clinical diagosis of type2diabetes 2-clinical diagnosis of hyperlpidemia 3-must be helpful patient 4-age below 70year Exclusion Criteria: 1-insulin dependant diabetes 2- pregnancy 3-heart disease 4- renal disease. 5-pregnancy -
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dalia galal mahran
    Phone
    01007120821
    Email
    daliaym2001@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Manal El-sayed Ezz-eldeen
    Phone
    01005826070
    Email
    manal_ezeldeen@yahoo.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    31139315
    Citation
    Jialal I, Singh G. Management of diabetic dyslipidemia: An update. World J Diabetes. 2019 May 15;10(5):280-290. doi: 10.4239/wjd.v10.i5.280.
    Results Reference
    background
    PubMed Identifier
    9673301
    Citation
    Haffner SM, Lehto S, Ronnemaa T, Pyorala K, Laakso M. Mortality from coronary heart disease in subjects with type 2 diabetes and in nondiabetic subjects with and without prior myocardial infarction. N Engl J Med. 1998 Jul 23;339(4):229-34. doi: 10.1056/NEJM199807233390404.
    Results Reference
    background
    PubMed Identifier
    4337382
    Citation
    Friedewald WT, Levy RI, Fredrickson DS. Estimation of the concentration of low-density lipoprotein cholesterol in plasma, without use of the preparative ultracentrifuge. Clin Chem. 1972 Jun;18(6):499-502. No abstract available.
    Results Reference
    background
    PubMed Identifier
    21772854
    Citation
    Sharifirad G, Entezari MH, Kamran A, Azadbakht L. The effectiveness of nutritional education on the knowledge of diabetic patients using the health belief model. J Res Med Sci. 2009 Jan;14(1):1-6.
    Results Reference
    background

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    Effectiveness of Nutritional Program Among Diabetic Patients

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