- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01671969
Very Low Calorie Diet for Diabetic Kidney Disease
August 27, 2015 updated by: Indiana University
The purpose of this study is to determine whether a very low calorie diet will stabilize or improve diabetic kidney disease.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: very low calorie diet
|
medically supervised diet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Urinary albumin excretion
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2012
Primary Completion (Actual)
March 1, 2014
Study Completion (Actual)
March 1, 2014
Study Registration Dates
First Submitted
March 20, 2012
First Submitted That Met QC Criteria
August 21, 2012
First Posted (Estimate)
August 24, 2012
Study Record Updates
Last Update Posted (Estimate)
August 28, 2015
Last Update Submitted That Met QC Criteria
August 27, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VLCD1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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