Reduced Calorie Diet Intervention in Kidney Transplant Recipients

NCT00994838 | Completed Phase 2

• 1 other identifier: 091030
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to measure the effect of a reduced calorie diet intervention in new kidney transplant recipients on the outcomes weight gain, oxidative stress, and insulin resistance.

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• a significant improvement in measures of body composition (including weight, BMI, and fat mass)

  12 months

Secondary Outcomes (3)

• an improvement in insulin resistance

  12 months

• a decrease in oxidative stress markers

  12 months

• an improvement in kidney function

  12 months

Study Arms (2)

reduced calorie diet

ACTIVE COMPARATOR

10% reduction in total daily calories (≈ 300 kcal reduction) from carbohydrates and fat from the usual daily energy consumption

Other: reduced calorie diet

standard diet

NO INTERVENTION

Interventions

reduced calorie diet OTHER

10% reduction in total daily calories (≈ 300 kcal reduction) from carbohydrates and fat from the usual daily energy consumption

reduced calorie diet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years to 65 years;
• BMI 25 to 40 kg/m2;
• First time kidney transplant;
• Single organ transplant;
• Ability to understand and voluntarily provide informed consent.

You may not qualify if:

• Type 1 DM;
• Type 2 DM on diabetic medications/insulin;
• Biopsy proven acute rejection in the first 3 months post transplant;
• Active coronary disease;
• Immunosuppressive therapy at time of transplant (use prior to what is given for transplant procedure);
• Atrial fibrillation (only for those undergoing the optional Pulse Wave Velocity);
• Hypersensitivity to organic nitrates, isosorbide, or nitroglycerin (only for those undergoing the optional brachial artery Doppler).

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kelly A Birdwell, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 12, 2009
• First Posted: October 14, 2009
• Study Start: October 1, 2009
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: July 17, 2015

Record last verified: 2015-07

Locations

US (1)