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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Diabetic Nephropathy, Medication Compliance

Intervention / Treatment
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* Other: low GI
* Other: low GI
* Other: conventional diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diabetic nephropathy, medication stable Exclusion Criteria: poor adherence of dietary recommendations, any changes in kind or dosage of medications

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: low GI<br>low GI: participants were asked to consume low GI foods (GI<55) in abundant, medium GI in moderate and high GI (GI>70) rarely. | Other: low GI<br>* 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.<br>|
| Experimental: low GL<br>low GL: participants were asked to consume low GI foods and the amount of carbohydrate was controlled. | Other: low GI<br>* 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.<br>|
| Experimental: conventional diet<br>conventional diet: all carbohydrate were treated as the same. | Other: conventional diet<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetic nephropathy, glycemic index, low glycemic load, inflammation