Lifestyle Management of CKD in Obese Diabetic Patients

Obesity Clinical Trial

Official title: Lifestyle Management of CKD in Obese Diabetic Patients

Status Completed

Clinical Trial Summary

The purpose of this randomized clinical trial is to evaluate the efficacy of 3 different technology-supported approaches to engaging 300 individuals with diabetes and concurrent chronic kidney disease in weight loss, dietary sodium restriction, and dietary restriction of inorganic phosphates when compared to usual care. Participants will be randomized to 1 of 4 groups, Usual Care (UC), Social Cognitive Theory-based Group Counseling (SCT), Mobile self-monitoring with tailored feedback and counseling (MONITORING), or a combination of SCT plus MONITORING conditions (COMBINED). Investigators will evaluate the intervention arms primarily in terms of weight reduction, urinary sodium excretion, and serum phosphorus and, secondarily in terms of physical activity, blood pressure, fasting lipids, medication requirements, and pulse wave velocity. Measurements will occur at baseline, 6, and 12 months. The statistical modeling of the baseline, 6 mos and 12 mos outcome variables will be based on logistic generalized linear mixed models (for binary outcomes) linear mixed models (for continuous outcomes), and random effects multinomial models (for outcomes with more than 2 levels, such as changes in medication management). In separate analyses of the intervention arm only, investigators will model self-monitoring adherence and examine possible associations between self-monitoring adherence and outcomes. The mediating effect of self-efficacy on the primary outcomes will be evaluated using structural equation models.

Clinical Trial Description

Investigators will conduct a 2x2 factorial, randomized clinical trial. All participants will receive usual care. Prior to randomization, participants will be stratified by recruitment siteParticipants will be randomized to 1 of 4 groups, Usual Care (UC), Social Cognitive Theory-based Group Counseling (SCT), Mobile self-monitoring with tailored feedback and counseling (MONITORING), or a combination of SCT plus MONITORING conditions (COMBINED). Investigators will evaluate the intervention arms primarily in terms of weight reduction, urinary sodium excretion, and serum phosphorus and, secondarily in terms of physical activity, blood pressure, fasting lipids, medication requirements, and pulse wave velocity. Measurements will occur at baseline, 6, and 12 months. The statistical modeling of the baseline, 6 mos and 12 mos outcome variables will be based on logistic generalized linear mixed models (for binary outcomes) linear mixed models (for continuous outcomes), and random effects multinomial models (for outcomes with more than 2 levels, such as changes in medication management). In separate analyses of the intervention arm only, investigators will model self-monitoring adherence and examine possible associations between self-monitoring adherence and outcomes. The mediating effect of self-efficacy on the primary outcomes will be evaluated using structural equation models

II. CHARACTERISTICS OF THE RESEARCH POPULATION

1. Number of subjects. Investigators will recruit 300 participants to the study. Investigators will focus our study on those with diabetic CKD as this form of the disease progresses more rapidly than other forms of CKD. Focusing on diabetic CKD also allows us to expand logically upon Look AHEAD, and build upon our work in T2DM patients with the ENHANCE study. Investigators will recruit participants from 3 clinical sites in New York City: Nephrology Family Group Practice at NYU Langone Medical Center (NYULMC), the Bellevue Hospital Diabetes Clinic, and New York Harbor VA. Preliminary data from these 3 practice settings indicate that investigators will have access to 4,292 potentially eligible patients from which investigators must recruit only 7.0% to enroll 300. Our prior studies suggest that investigators will retain 80% resulting in a final sample of 240. Investigators are projecting 64 participant measurement visits in Year 1; 248 in Year 2; 288 in Year 3; 244 in Year 4; and 56 in Year 5.

Unless otherwise noted, measurements occur at baseline, 6, and 12 mos. Data are collected with visits to NYU Clinical and Translational Resource Center (CTRC). Information to be obtained from participants at each visit includes height and weight, serum and urine samples; blood pressure; investigator administered instruments (sociodemographics, comorbid conditions, Mini Mental Status Exam, and self-efficacy instruments), medication inventories, and Pulse Wave Velocity. Eight blood tests will be performed: cystatin-C, lipids, phosphorus, calcium, PTH or parathyroid hormone, vitamin D, pre-albumin and albumin. These tests are estimated to require, in total, approximately 45 mls (of blood.

One week before their scheduled measurement visit, a 24-hour urine specimen container and instructions for collection are mailed to the participant. Participants are contacted 2 days prior to their appointment to remind them of their measurement visit, collect their urine, fast, and abstain from caffeine for 12 hours prior to their appointment. Laboratory tests are collected, spun, refrigerated, batched and sent for processing in the CLIA-certified NYU CTSI Translational Research Laboratories by personnel blinded to group assignment. The PWV of the brachial-ankle (baPWV) and carotid-femoral (cfPWV) will be collected by trained research associates at the CTRC. ;

Related Conditions & MeSH terms

• Chronic Kidney Disease (CKD)
• Kidney Diseases
• Obesity
• Renal Insufficiency, Chronic
• Type 2 Diabetes

• NCT number: NCT02276742
• Study type: Interventional
• Source: NYU Langone Health
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Completion date: November 8, 2019