The Feasibility of a Diet and Exercise Intervention in Diabetics During Treatment for Non-muscle Invasive Bladder Cancer (DEAL)

July 11, 2019 updated by: Eugene Lee, MD, University of Kansas Medical Center
The purpose of this study is to learn if bladder cancer patients can follow a diet and exercise program during treatment and whether the program will improve results of their treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will examine the effects of a carbohydrate restricted (CR) diet in bladder cancer patients with diabetes. The goal of this pilot study is to determine if the CR diet and exercise routine are feasible for this patient population to follow.

Participants in this study will receive meals tailored to their specific needs. A registered dietitian will work with them to establish guidelines for the meals and to follow their progress throughout the study.

Participants will be asked to be in this study for up to 12 months. A participant will be asked to make a total of 16 in-person visits over the course of 12 months.

Study Type

Interventional

Enrollment (Actual)

5

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

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Cancer Center

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:

  • Diagnosis of non-muscle-invasive bladder cancer
  • Have completed Transurethral Resection of Bladder Tumor (TURBT) procedure
  • Diagnosis of diabetes or pre-diabetes, or use diabetic medication, or show signs of diabetes which would prompt a diabetic screening

Exclusion Criteria:

  • Evidence of muscle-invasion or metastatic disease
  • BMI less than 18.5 and/or score in the "severe malnourished" category of the patient generated subjective global assessment (PGSGA)
  • Unable to complete the exercise regimen or deemed a fall risk
  • Participating in a research study involving any form of treatment intervention

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: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CR Diet and Exercise
Participants will be asked to follow specific diet intervention and exercise regimen.
Other: CR diet
Diet consists of meals lower in carbohydrates but does not restrict the number of calories that participants can consume.
Other Names:
  • Carbohydrate restricted diet
Behavioral: Exercise
Participants will be asked to undergo specific exercise schedule. Exercise will be tracked using a fitness device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant compliance with study specific CR diet
Time Frame: 12 months
Measure participant compliance with CR diet. Compliance will be measured through adherence to study diet. Study team members will regularly check in with participants to track weekly food data.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of Tumor M2-PK
Time Frame: 12 months
Level of Tumor M2-PK will be assessed over the course the study.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Collaborators

National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Eugene Lee, MD, University of Kansas Medical Center

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, 2016

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

May 1, 2019

Study Registration Dates

First Submitted

March 10, 2016

First Submitted That Met QC Criteria

March 17, 2016

First Posted (Estimate)

March 23, 2016

Study Record Updates

Last Update Posted (Actual)

July 15, 2019

Last Update Submitted That Met QC Criteria

July 11, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00001802
  • UL1TR000001 (U.S. NIH Grant/Contract)

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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