Effectiveness of Nutritional Program Among Diabetic Patients

Assiut University

Status: Unknown

Conditions: Dyslipidemia Associated With Type II Diabetes Mellitus

Treatments: Other: DASH diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05128747

Eonpifcolpadp

Details and patient eligibility

About

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

Full 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).

Enrollment: 190 estimated patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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190 participants in 2 patient groups

group of intervention will receive nutritional program

Active Comparator group

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.

Treatment:

Other: DASH diet

group of control will not receive nutritional program

No Intervention group

Description:

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