Very Low Calorie Diet for Diabetic Kidney Disease

N/ACompletedNCT01671969

Indiana University10 enrolled

Overview

The purpose of this study is to determine whether a very low calorie diet will stabilize or improve diabetic kidney disease.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetic Kidney Disease

Interventions

very low calorie dietOTHER

medically supervised diet

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type 2 Diabetes * Age \> 18 * Body mass index ≥ 30 * Presumed or biopsy-proven diabetic nephropathy * Estimated GFR \< 40 ml/min/1.73 meters squared * Proteinuria \> 0.5 gm/day * Motivated to lose weight * Stable medical co-morbidities * Using an ACE inhibitor or angiotensin receptor blocker agent (unless contraindicated) Exclusion Criteria: * Inability to sign informed consent * Life expectancy of \< 1 year * Expected need for initiation of dialysis within 9 months * Type 1 Diabetes * Recent myocardial infarction or stroke (past 3 months) * Unstable angina * Active cancer * Pregnancy/lactation * Serious psychiatric diseases * Substance abuse * Uncontrolled hypertension (\> 180/110) * Ineligible for VLCD based on laboratory data

Locations (1)

University Hospital

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

Urinary albumin excretion

Time frame: 3 months

Data from ClinicalTrials.gov

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