NCT05128747

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
190

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 22, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

November 22, 2021

Status Verified

November 1, 2021

Enrollment Period

7 months

First QC Date

September 15, 2021

Last Update Submit

November 17, 2021

Conditions

Dyslipidemia Associated With Type II Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • 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 .

    3-6 months

Study Arms (2)

group of intervention will receive nutritional program

ACTIVE COMPARATOR

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.

Other: DASH diet

group of control will not receive nutritional program

NO INTERVENTION

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

Interventions

DASH dietOTHER

it will be face to face about the role of nutritional program to control dyslipidemia

group of intervention will receive nutritional program

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 31139315BACKGROUND

  • 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.

    PMID: 9673301BACKGROUND

  • 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.

    PMID: 4337382BACKGROUND

  • 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.

    PMID: 21772854BACKGROUND

MeSH Terms

Interventions

Dietary Approaches To Stop Hypertension

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Central Study Contacts

Dalia galal mahran

CONTACT

01007120821daliaym2001@yahoo.com

Manal El-sayed Ezz-eldeen

CONTACT

01005826070manal_ezeldeen@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: diabetic patients type2 with dyslipidemia
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 15, 2021

First Posted

November 22, 2021

Study Start

March 1, 2022

Primary Completion

October 1, 2022

Study Completion

December 30, 2022

Last Updated

November 22, 2021

Record last verified: 2021-11