Leukocyte Telomere Length: Diet and Exercise Trial


  • Org Study ID: CA212628
  • Secondary ID: R21CA212628
  • NCT ID: NCT03286699
  • Sponsor: University of Pittsburgh


The goal of the research is to provide a first critical test of the novel scientific idea
that a combined diet and exercise intervention may ameliorate shortening of leukocyte
telomere length (LTL) in individuals with histories of successfully treated non-metastatic
bladder cancer (BC) or colorectal adenoma (CRA) compared to a diet only intervention.

  • Overall Status
  • Start Date
    June 1, 2017
  • Phase
  • Study Type


Primary Outcome 1 - Measure: Leukocyte telomere length (LTL) at the 6 month assessment (controlling for appropriate covariates)

Primary Outcome 1 - Timeframe: Blood samples will be collected as part of the 6 month assessment


  • Bladder Cancer
  • Telomere Shortening
  • Colorectal Adenoma


Inclusion Criteria:

- BMI between 25.0 to <40 kg/m2 (allows for use of assessments such as DXA to be

- History of histologically confirmed bladder cancer (non-metastatic) or colorectal

- Under clinical surveillance with no evidence of disease

Exclusion Criteria:

- WHO performance status 3-4 or deemed physically unable to participate by physician

- Currently pregnant or breastfeeding, were pregnant in the previous 6 months or
breastfeeding in the previous 3 months, or planning pregnancy in the next year

- History of bariatric surgery

- Medical condition that could affect body weight (e.g., diabetes mellitus,
hyperthyroidism, uncontrolled hypothyroidism, chronic renal insufficiency, chronic
liver disease, gastrointestinal disorders including ulcerative colitis)

- Cancer diagnosis (other than bladder cancer or non-melanoma skin cancer) in the
previous 5 years

- Current congestive heart failure, signs or symptoms indicative of an increased acute
risk for a cardiovascular event

- History of myocardial infarction, coronary artery bypass or angioplasty, conditions
requiring chronic anticoagulation (recent or recurrent DVT)

- Resting systolic blood pressure of >160 mmHg or diastolic blood pressure >100 mmHg

- Eating disorder that would contraindicate weight loss or physical activity

- Alcohol or substance abuse

- Current treatment for psychiatric issues (e.g., depression, bipolar disorder) or
taking daily or extended release psychotropic medications in the previous 12 months

- Report exercising more than 100 minutes per week over the past 3 months (NOTE:
includes physical activity performed for sport, fitness, or recreational activity;
physical activity performed as part of occupation or household chores is not included)

- Weight loss of greater than 5% or participating in a weight reduction diet in the past
3 months

- Report plans to relocate to a location not accessible to the study site or having
employment, personal, or travel commitments that prohibit attendance to at least 80
percent of the scheduled intervention sessions and all of the scheduled assessments

Gender: All

Minimum Age: 84 Years

Maximum Age: 18 Years

Healthy Volunteers: No


Name: Dana Bovbjerg, PhD

Role: Principal Investigator

Affiliation: University of Pittsburgh

Overall Contact

Name: Dana Bovbjerg, PhD

Phone: 412-623-8942

Email: mancjf@upmc.edu


Facility Status Contact
Facility: UPMC Shadyside
Pittsburgh, Pennsylvania 15232
United States
Status: Recruiting Contact: Jessica Manculich