Very Low Calorie Diet for Diabetic Kidney Disease

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01671969

Enrollment

Registered

2012-08-24

Start date

2012-03-31

Completion date

2014-03-31

Last updated

2015-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Kidney Disease

Keywords

determine effects of diet on renal and other parameters

Brief summary

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

Interventions

OTHERvery low calorie diet

medically supervised diet

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Urinary albumin excretion	3 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026