Very Low Calorie Diet for Diabetic Kidney Disease

Diabetic Kidney Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01671969
• Other study ID #: VLCD1
• Status: Completed
• Phase: N/A
• First received: March 20, 2012
• Last updated: August 27, 2015
• Start date: March 2012
• Est. completion date: March 2014

Study information

• Verified date: August 2015
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Kidney Disease
• Diabetic Nephropathies
• Kidney Diseases

Intervention

Other:
• very low calorie diet
medically supervised diet

Locations

Country	Name	City	State
United States	University Hospital	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary albumin excretion		3 months	No