Very Low Calorie Diet for Diabetic Kidney Disease

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

Completed

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Key information

Conditions

Diabetic Kidney Disease Diabetes Complications Diabetes Mellitus Diabetic Nephropathies Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Indianapolis, Indiana, 46202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

very low calorie diet

Other

medically supervised diet

Primary outcomes

Urinary albumin excretion

Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: Aug 24, 2012
Registry last updated: Aug 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed