NCT01671969

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2012

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 24, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

August 28, 2015

Status Verified

August 1, 2015

Enrollment Period

2 years

First QC Date

March 20, 2012

Last Update Submit

August 27, 2015

Conditions

Diabetic Kidney Disease

Keywords

determine effects of diet on renal and other parameters

Outcome Measures

Primary Outcomes (1)

  • Urinary albumin excretion

    3 months

Study Arms (1)

very low calorie diet

EXPERIMENTAL
Other: very low calorie diet

Interventions

very low calorie dietOTHER

medically supervised diet

very low calorie diet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

  • Friedman AN, Chambers M, Kamendulis LM, Temmerman J. Short-term changes after a weight reduction intervention in advanced diabetic nephropathy. Clin J Am Soc Nephrol. 2013 Nov;8(11):1892-8. doi: 10.2215/CJN.04010413. Epub 2013 Aug 8.

    PMID: 23929927DERIVED

MeSH Terms

Conditions

Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2012

First Posted

August 24, 2012

Study Start

March 1, 2012

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

August 28, 2015

Record last verified: 2015-08

Locations

US(1)