Very Low Calorie Diet for Diabetic Kidney Disease

This study has suspended participant recruitment.

Sponsor:

Information provided by (Responsible Party):

Indiana University

ClinicalTrials.gov Identifier:

NCT01671969

First received: March 20, 2012

Last updated: April 1, 2013

Last verified: March 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	March 20, 2012
Last Updated Date	April 1, 2013
Start Date ^ICMJE	March 2012
Estimated Primary Completion Date	March 2014 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 28, 2012)	Urinary albumin excretion [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: August 21, 2012)	Change in weight [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT01671969 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Very Low Calorie Diet for Diabetic Kidney Disease
Official Title ^ICMJE	Not Provided
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
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Diabetic Kidney Disease
Intervention ^ICMJE	Other: very low calorie diet medically supervised diet
Study Arm (s)	Experimental: very low calorie diet Intervention: Other: very low calorie diet
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Suspended
Estimated Enrollment ^ICMJE	10
Estimated Completion Date	March 2014
Estimated Primary Completion Date	March 2014 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01671969
Other Study ID Numbers ^ICMJE	VLCD1
Has Data Monitoring Committee	No
Responsible Party	Indiana University
Study Sponsor ^ICMJE	Indiana University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Indiana University
Verification Date	March 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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