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

NCT02384902 | Completed

• 1 other identifier: low GI nephropathy
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Nephropathy; Medication Compliance

Keywords

glycemic index; diabetic nephropathy; low glycemic load; inflammation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Other Outcomes (1)

• 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

Study Arms (3)

low GI

EXPERIMENTAL

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

low GL

EXPERIMENTAL

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

Other: low GI

conventional diet

EXPERIMENTAL

conventional diet: all carbohydrate were treated as the same.

Other: conventional diet

Interventions

low GI OTHER

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

conventional diet OTHER

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

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diabetic nephropathy, medication stable

You may not qualify if:

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

Sponsors & Collaborators

• Isfahan University of Medical Sciences: lead

Study Sites (1)

Leila Azadbakht

Isfahan, Isfahan, Iran

Location

MeSH Terms

Conditions

Diabetic Nephropathies; Medication Adherence; Inflammation

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• leila azadbakht, phd

  Isfahan University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Leila Azadbakht

Study Record Dates

• First Submitted: September 6, 2014
• First Posted: March 10, 2015
• Study Start: May 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: March 10, 2015

Record last verified: 2015-03

Locations

IR (1)