Very Low Calorie Diet for Diabetic Kidney Disease

Indiana University

Status: Completed

Conditions: Diabetic Kidney Disease

Treatments: Other: very low calorie diet

Study type: Interventional

Funder types: Other

Identifiers

NCT01671969

VLCD1

Details and patient eligibility

About

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

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

very low calorie diet

Experimental group

Treatment:

Other: very low calorie diet