Effect of Low GI/ Glycemic Load (GL) Diet in Diabetic Nephropathy Patients

Diabetic Nephropathy Clinical Trial

Official title:

Effect of Dietary Glycemic Index/Load on Kidney-related Biomarkers and Inflammation in Diabetic Nephropathy Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02384902
• Other study ID #: low GI nephropathy
• Status: Completed
• Phase: N/A
• First received: September 6, 2014
• Last updated: March 9, 2015
• Start date: May 2014
• Est. completion date: July 2014

Study information

• Verified date: March 2015
• Source: Isfahan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

low GI and low GL diet have more beneficial effect for diabetic nephropath patients compared with conventional diet.

low GL may have more favorable effect than low GI diet.

Description:

According to body weight status of participants, the investigators considered a slight calorie restriction ranged from 200 to 300 Kcal/d. Planed meals and exchange list prescribed for all volunteers. Dietary records forms were given to all subjects and they were educated how to record their dietary intakes. The investigators asked subjects not to change their physical activity level during the study and monitored them for their physical activity level by 3 days physical activity records monthly.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

Inclusion Criteria:

• diabetic nephropathy, medication stable

Exclusion Criteria:

• poor adherence of dietary recommendations, any changes in kind or dosage of medications

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Diabetic Nephropathy
• Kidney Diseases
• Medication Compliance

Intervention

Other:
• low GI
All diets were designed with similar macronutrients content (30% fat, 0.8 g/kg/d protein and remained calorie requirement by carbohydrate). Additionally, we controlled phosphorus, sodium and potassium content of diets for three intervention groups. All dietary menus had less than 1500 mg phosphor and less than 2400 mg sodium and 2000 mg potassium.
• low GI
All diets were designed with similar macronutrients content (30% fat, 0.8 g/kg/d protein and remained calorie requirement by carbohydrate). Additionally, we controlled phosphorus, sodium and potassium content of diets for three intervention groups. All dietary menus had less than 1500 mg phosphor and less than 2400 mg sodium and 2000 mg potassium.
• conventional diet
All diets were designed with similar macronutrients content (30% fat, 0.8 g/kg/d protein and remained calorie requirement by carbohydrate). Additionally, we controlled phosphorus, sodium and potassium content of diets for three intervention groups. All dietary menus had less than 1500 mg phosphor and less than 2400 mg sodium and 2000 mg potassium.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Leila Azadbakht	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fasting blood sugar (FBS) and lipid profile concentrations (mg/dl) were measured using commercially available enzymatic reagents adopted to an auto-analyzer system.		baseline, wk 12	Yes
Primary	Serum creatinine (and blood urea nitrogen (BUN) (mg/dL) were measured by colorimetric method and enzymatic colorimetric method using commercial assay kit.		baseline, wk 12	Yes
Secondary	Serum levels of high sensitive C- reactive protein (hs-CRP) (mg/L) were quantified by using an ultrasensitive latex-enhanced immunoturbidimetric assay (Randox Laboratory Ltd., Belfast, United Kingdom).		baseline, wk 12	Yes