Diabetes Mellitus Clinical Trial
— DEALOfficial title:
The Feasibility of a Diet and Exercise Intervention in Diabetics During Treatment for Non-muscle Invasive Bladder Cancer
Verified date | July 2019 |
Source | University of Kansas Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 5 |
Est. completion date | May 1, 2019 |
Est. primary completion date | May 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Kansas Cancer Center | Kansas City | Kansas |
United States | University of Kansas Medical Center | Kansas City | Kansas |
Lead Sponsor | Collaborator |
---|---|
University of Kansas Medical Center | National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Participant compliance with study specific CR diet | 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 | Presence of Tumor M2-PK | Level of Tumor M2-PK will be assessed over the course the study. | 12 months |
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