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

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.

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Key information

Conditions

Bladder Cancer Diabetes Mellitus Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Male Urogenital Diseases Metabolic Diseases Neoplasms Neoplasms by Site Nutritional and Metabolic Diseases Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Cancer Center, Kansas City, Kansas, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CR diet

Other

Diet consists of meals lower in carbohydrates but does not restrict the number of calories that participants can consume.

Other names: Carbohydrate restricted diet

Exercise

Behavioral

Participants will be asked to undergo specific exercise schedule. Exercise will be tracked using a fitness device.

Primary outcomes

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.

Secondary outcomes

Presence of Tumor M2-PK

Time frame: 12 months

Level of Tumor M2-PK will be assessed over the course the study.

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

National Institutes of Health (NIH)

Registry information

Acronym: DEAL

Important dates

Study start: 2016
Primary completion: 2019
Study completion: 2019
First posted: Mar 23, 2016
Registry last updated: Jul 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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