Very Low Calorie Diet for Diabetic Kidney Disease | NCT01671969

Studies
Very Low Calorie Diet for Diabetic Kidney Disease

NCT01671969

Sponsor

Indiana University

Status

Completed

Last Update Posted

Aug 28, 2015Estimated

Enrollment

10Actual

Phase

Not Applicable

Conditions

Diabetic Kidney Disease

Interventions

very low calorie diet

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2012

Primary Completion Date

Mar 2014Actual

Completion Date

Mar 2014Actual

First Submitted Date

Mar 20, 2012

First Submission Date that Met QC Criteria

Aug 21, 2012

First Posted Date

Aug 24, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 27, 2015

Last Update Posted Date

Aug 28, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
very low calorie diet	Experimental		Other: very low calorie diet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
very low calorie diet	Other	medically supervised diet	very low calorie diet

Measure	Description	Time Frame
Urinary albumin excretion		3 months

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital		Indianapolis	Indiana	46202	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23929927	Derived	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.

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications