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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02384902
Other study ID # low GI nephropathy
Secondary ID
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


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
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