Effectiveness of Nutritional Program Intervention for Control of Lipid Profile Among Diabetic Patients
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Assiut University
- Enrollment
- 190
- Primary Endpoint
- Evaluate the effectiveness of one of the most common dietary approches;DASH diet in controlling lipid profile in diabetic patients.
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 30 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
group of intervention will receive nutritional program
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.
Intervention: DASH diet (Other)
group of control will not receive nutritional program
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 Outcomes
Evaluate the effectiveness of one of the most common dietary approches;DASH diet in controlling lipid profile in diabetic patients.
Time Frame: 3-6 months
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 Outcomes
No secondary outcomes reported
Investigators
Gehad M Galal
Principal Investigator
Assiut University