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

Primary Purpose

Diabetic Nephropathy, Medication Compliance

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
low GI
low GI
conventional diet
Sponsored by
Isfahan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Nephropathy focused on measuring glycemic index, diabetic nephropathy, low glycemic load, inflammation

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • diabetic nephropathy, medication stable

Exclusion Criteria:

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

Sites / Locations

  • Leila Azadbakht

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

low GI

low GL

conventional diet

Arm Description

low GI: participants were asked to consume low GI foods (GI<55) in abundant, medium GI in moderate and high GI (GI>70) rarely.

low GL: participants were asked to consume low GI foods and the amount of carbohydrate was controlled.

conventional diet: all carbohydrate were treated as the same.

Outcomes

Primary Outcome Measures

Serum creatinine (and blood urea nitrogen (BUN) (mg/dL) were measured by colorimetric method and enzymatic colorimetric method using commercial assay kit.

Secondary Outcome Measures

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).

Full Information

First Posted
September 6, 2014
Last Updated
March 9, 2015
Sponsor
Isfahan University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02384902
Brief Title
Effect of Low GI/ Glycemic Load (GL) Diet in Diabetic Nephropathy Patients
Official Title
Effect of Dietary Glycemic Index/Load on Kidney-related Biomarkers and Inflammation in Diabetic Nephropathy Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isfahan University of Medical Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Nephropathy, Medication Compliance
Keywords
glycemic index, diabetic nephropathy, low glycemic load, inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
low GI
Arm Type
Experimental
Arm Description
low GI: participants were asked to consume low GI foods (GI<55) in abundant, medium GI in moderate and high GI (GI>70) rarely.
Arm Title
low GL
Arm Type
Experimental
Arm Description
low GL: participants were asked to consume low GI foods and the amount of carbohydrate was controlled.
Arm Title
conventional diet
Arm Type
Experimental
Arm Description
conventional diet: all carbohydrate were treated as the same.
Intervention Type
Other
Intervention Name(s)
low GI
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
low GI
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
conventional diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Serum creatinine (and blood urea nitrogen (BUN) (mg/dL) were measured by colorimetric method and enzymatic colorimetric method using commercial assay kit.
Time Frame
baseline, wk 12
Secondary Outcome Measure Information:
Title
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).
Time Frame
baseline, wk 12
Other Pre-specified Outcome Measures:
Title
Fasting blood sugar (FBS) and lipid profile concentrations (mg/dl) were measured using commercially available enzymatic reagents adopted to an auto-analyzer system.
Time Frame
baseline, wk 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diabetic nephropathy, medication stable Exclusion Criteria: poor adherence of dietary recommendations, any changes in kind or dosage of medications
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
leila azadbakht, phd
Organizational Affiliation
Isfahan University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Leila Azadbakht
City
Isfahan
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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

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