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Trial record 59 of 109 for:    CALCIUM CATION

PTH And Calcium Responses to Exercise (PACE) in Older Adults

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ClinicalTrials.gov Identifier: NCT02468817
Recruitment Status : Completed
First Posted : June 11, 2015
Last Update Posted : March 14, 2018
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Tracking Information
First Submitted Date  ICMJE June 2, 2015
First Posted Date  ICMJE June 11, 2015
Last Update Posted Date March 14, 2018
Study Start Date  ICMJE August 2015
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 21, 2016)
  • Change in Parathyroid Hormone (PTH) [ Time Frame: 60 minutes of exercise and 2 hours of recovery ]
    PTH will be measured during baseline, throughout exercise, and during recovery at regular intervals. We are looking to see how PTH changes over the course of the exercise and recovery period in both the warm and cool conditions. We anticipate that PTH will be higher in the warm condition versus the cool. We expect that men and women will respond similarly.
  • Change C-Telopeptide (CTX) [ Time Frame: 60 minutes of exercise and 2 hours of recovery ]
    CTX will be measured during baseline, throughout exercise, and during recovery at regular intervals. We are looking to see how PTH changes over the course of the exercise and recovery period in both the warm and cool conditions. We anticipate that CTX will be higher during exercise and recovery in the warm condition versus the cool.
  • Change in Serum Ionized Calcium (iCa) [ Time Frame: 60 minutes of exercise ]
    iCa will be measured during baseline, throughout exercise, and during recovery at regular intervals. We are looking to see how PTH changes over the course of the exercise and recovery period in both the warm and cool conditions. We expect that serum iCa will be higher in the cool condition versus the warm.
  • Change in Total Ca [ Time Frame: 60 minutes of exercise ]
    Total Ca will be measured during baseline, throughout exercise, and during recovery at regular intervals. We are looking to see how PTH changes over the course of the exercise and recovery period in both the warm and cool conditions.
Original Primary Outcome Measures  ICMJE
 (submitted: June 8, 2015)
  • Change in Parathyroid Hormone (PTH) [ Time Frame: 60 minutes of exercise and 2 hours of recovery ]
    PTH will be measured during baseline, throughout exercise, and during recovery at regular intervals. We are looking to see how PTH changes over the course of the exercise and recovery period in both the warm and cool conditions. We anticipate that PTH will be higher in the warm condition versus the cool. We expect that men and women will respond similarly.
  • Change C-Telopeptide (CTX) [ Time Frame: 60 minutes of exercise and 2 hours of recovery ]
    CTX will be measured during baseline, throughout exercise, and during recovery at regular intervals. We are looking to see how PTH changes over the course of the exercise and recovery period in both the warm and cool conditions. We anticipate that CTX will be higher during exercise and recovery in the warm condition versus the cool.
  • Change in Serum Ionized Calcium (iCa) [ Time Frame: 60 minutes of exercise ]
    iCa will be measured during baseline, throughout exercise, and during recovery at regular intervals. We are looking to see how PTH changes over the course of the exercise and recovery period in both the warm and cool conditions. We expect that serum iCa will be higher in the cool condition versus the warm.
  • Chaneg in Total Ca [ Time Frame: 60 minutes of exercise ]
    Total Ca will be measured during baseline, throughout exercise, and during recovery at regular intervals. We are looking to see how PTH changes over the course of the exercise and recovery period in both the warm and cool conditions.
Change History Complete list of historical versions of study NCT02468817 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PTH And Calcium Responses to Exercise (PACE) in Older Adults
Official Title  ICMJE PTH And Calcium Responses to Exercise (PACE) in Older Adults
Brief Summary Exercise that causes a decline in serum Calcium (Ca) as a result of dermal Ca loss stimulates bone resorption via an increase in Parathyroid Hormone (PTH).
Detailed Description Determine whether the magnitude of dermal Ca loss (i.e., sweating) during exercise is a determinant of the decline in iCa and increases in PTH and carboxy-terminal collagen crosslinks (CTX; marker of bone resorption). The proposed experiment will address this by manipulating the rate of dermal Ca loss (moderate vs high sweating rate) to determine whether this is the trigger for the cascade described in Figure 1. This will be achieved by having participants perform two identical exercise bouts under different thermal conditions (warm vs cool).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Osteoporosis
Intervention  ICMJE
  • Procedure: Treadmill Exercise
    2 (two) 1-hour of vigorous exercise bouts under different thermal conditions
  • Procedure: Magnitude of Ca loss during Exercise at 26 degrees Celcius
    Blood samples at 15-min intervals starting 15 min before exercise and ending 60 min after exercise
Study Arms  ICMJE
  • Active Comparator: Treadmill Exercise
    2 (two) 1-hour of vigorous exercise bouts under different thermal conditions, one at 16 degrees C and one at 26 degrees C.
    Intervention: Procedure: Treadmill Exercise
  • Experimental: Magnitude of Ca loss during Exercise at 26 degrees Celcius
    Blood samples at 15-min intervals starting 15 min before exercise and ending 60 min after exercise.
    Intervention: Procedure: Magnitude of Ca loss during Exercise at 26 degrees Celcius
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 12, 2018)
12
Original Estimated Enrollment  ICMJE
 (submitted: June 8, 2015)
32
Actual Study Completion Date  ICMJE January 2018
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy adults aged 60-80 y

Exclusion Criteria:

  • Use of medications in the past 6 months known to affect bone metabolism (e.g., bisphosphonates, thiazide diuretics, oral glucocorticoids)
  • BMD t score < -2.5 at the total hip or lumbar spine
  • Known disease or condition associated with intestinal malabsorption
  • Moderate or severe renal impairment defined as an estimated glomerular filtration rate of <60 mL/min/1.73m2 based on the MDRD equation
  • Chronic hepatobiliary disease, defined as liver function tests (AST, ALT) >1.5 times the upper limit of normal; if such values are obtained on initial screening and thought to be transient in nature, repeated testing will be allowed
  • Thyroid dysfunction, defined as an ultrasensitive TSH <0.5 or >5.0 mU/L; volunteers with abnormal TSH values will be re-considered for participation in the study after follow-up evaluation by the PCP with initiation or adjustment of thyroid hormone replacement
  • Serum calcium <8.5 or >10.3 mg/dL
  • Serum 25(OH)D <20 ng/mL; volunteers with abnormal serum 25(OH)D values may be re-considered for participation in the study if serum 25(OH)D is >20 ng/mL after vitamin D supplementation
  • Uncontrolled hypertension defined as resting systolic BP >150 mmHg or diastolic BP>90 mmHg; participants who do not meet these criteria at first screening will be re-evaluated, including after follow-up evaluation by the PCP with initiation or adjustment of anti-hypertensive medications
  • History of type 1 or type 2 diabetes
  • Cardiovascular disease; subjective or objective indicators of ischemic heart disease (e.g., angina, ST segment depression) or serious arrhythmias at rest or during the graded exercise test (GXT) without follow-up evaluation will be cause for exclusion; follow-up evaluation must include diagnostic testing (e.g., stress echocardiogram or thallium stress test) with interpretation by a cardiologist
  • Diagnosis or history of asthma
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02468817
Other Study ID Numbers  ICMJE 15-0250
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Colorado, Denver
Study Sponsor  ICMJE University of Colorado, Denver
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sarah J Wherry, PhD University of Colorado, Denver
PRS Account University of Colorado, Denver
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP