Trial document





This trial has been registered retrospectively.
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  DRKS00020425

Trial Description

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Title

Effects of acute aerobic exercise and endurance training on fat metabolism and thyroid function in pre- and postmenopausal women

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Trial Acronym

EAAEETFMTFPPW

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URL of the Trial

http:///

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Brief Summary in Lay Language

Thus research project will investigate how fat metabolism behaves during and after an acute endurance training with young (18-30 years) and older (50-65 years) women. Furthermore, it will be examined how a six-week endurance training intervention affects the fat metabolism in older women. For this purpose, two common methods will be combined and subsequently compared. Spiroergometry is a common examination method for measuring fat metabolism. In this form of indirect calorimetry, the O2 consumption is measured and from this, the amount of energy consumed is determined by reference to the caloric equivalent. The respiratory quotient, among other things, provides information at the end about which substrate (fats, proteins or carbohydrates) was primarily used to provide energy. Isotope analysis using infrared spectrometry (IRIS) is another method for analysing substrate flows. So far, these two measuring methods have not been combined and compared with each other. Therefore, in the context of this study, both measuring methods are to be applied in parallel - for both younger and older women - during an endurance exposure. The older women repeat the measurement after a six-week intervention.
Furthermore, the influence of endurance training on changes in the thyroid hormones TSH, fT4 and fT3 will be investigated and differences between pre- and postmenopausal women will be identified. For this purpose, the parameters will be recorded acutely and after the intervention. The data situation regarding the effects of sports activities on thyroid hormone concentrations is poor. The planned study should provide insight into the influence of endurance training on thyroid hormone concentrations in older women.

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Brief Summary in Scientific Language

The research project will investigate how fat metabolism behaves during and after acute endurance training in pre- and postmenopausal women. In addition, it will be investigated how a six-week endurance training intervention affects the lipid metabolism in postmenopausal women. For this purpose, two common methods will be combined and subsequently compared. The spiroergometry is a common method for measuring fat metabolism. In this form of indirect calorimetry, O2 consumption is measured and the amount of energy consumed is determined by reference to the caloric equivalent. The respiratory quotient, among other things, provides information about which substrate (fats, proteins or carbohydrates) was primarily used to provide energy. Isotope analysis using infrared spectrometry (IRIS) is another method for analysing substrate flows. So far, these two measuring methods have not been combined and compared with each other. Therefore, in this study both measuring methods will be applied in parallel - both in premenopausal and postmenopausal women - during endurance exercise. The postmenopausal women repeat the measurement after a six-week intervention.
Furthermore, the influence of endurance training on changes in the thyroid hormones TSH, fT4 and fT3 will be investigated and differences between pre- and postmenopausal women will be identified. For this purpose, the parameters will be recorded acutely and after the intervention. The data situation regarding the effects of sports activities on thyroid hormone concentrations is poor. The planned study should provide insight into the influence of endurance training on thyroid hormone concentrations in postmenopausal women.

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Do you plan to share individual participant data with other researchers?

Yes

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Description IPD sharing plan:

The data should be made available to other researchers in anonymised form within the framework of a publication. Personal data such as age, sex, height and gender will be published, as well as changes in thyroid hormone concentration and the data collected from respiratory gas analyses. Furthermore, detailed information on the study design will be made available. After completion of the intervention, the paper will be prepared as soon as possible and published in 2020.

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Organizational Data

  •   DRKS00020425
  •   2020/01/23
  •   [---]*
  •   yes
  •   Approved
  •   139/2019, Deutsche Sporthochschule Köln
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   E03.9 -  Hypothyroidism, unspecified
  •   E71.3 -  Disorders of fatty-acid metabolism
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Interventions/Observational Groups

  •   Determination of the hormones TSH, fT4 and fT3 at 9:00 am and 9:40 am without training.

    Execution of a 30-minute endurance training on the bicycle ergometer at 60% of the 4mmol lactate threshold with pre- and postmenopausal women on another measuring day. Before and after the exercise the thyroid hormones TSH, fT4 and fT3 are measured.

    The postmenopausal women then undergo a six-week intervention during which they complete three 45-minute training sessions on the bicycle ergometer each week.

    After completion of the intervention, the initial measurement is repeated.
  •   Collection of a total of 7 respiratory gas samples at 30-minute intervals via spiroergometry and infrared spectrometry in pre- and postmenopausal women.

    On another measurement day, 7 breathing gas samples are again taken and an additional 30-minute endurance training is carried out on the bicycle ergometer at 60 % of the 4 mmol threshold.

    The postmenopausal women then carry out a six-week endurance training session, during which they complete 45-minute training units on the bicycle ergometer three days a week.

    After completion of the intervention, the entrance test is repeated.
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Characteristics

  •   Interventional
  •   [---]*
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

After completion of all measurements (hormones and breathing samples) after the intervention of the postmenopausal women. The end point is reached when all subjects have successfully completed the final testing period.

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Secondary Outcome

not applicable

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2019/12/02
  •   24
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

Premenopausal subjects:
female, premenopausal (< 30 years), regular menstrual cycle.

Postmenopausal subjects: female, postmenopausal (50-65 years).

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Exclusion Criteria

> 2 times endurance training per week, unbalanced nutrition (e.g. vegan), hormone substitution (incl. oral contraceptives), hormonal diseases, cardiac arrhythmia requiring treatment, metabolic diseases, heart failure (EF < 55), performance-limiting PAD (Fontaine stage ≥ II), performance-limiting respiratory diseases, performance-limiting degenerative diseases, performance-limiting muscular diseases, performance-limiting kidney diseases, performance-limiting neurological diseases, psychiatric and/or addiction diseases, performance-limiting oncological diseases in the past (< 5 years)

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Addresses

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    • Deutsche Sporthochschule Köln - Institut für Kreislaufforschung und Sportmedizin
    • Mr.  Prof.  Patrick  Diel 
    • Am Sportpark Müngersdorf6
    • 50933  Köln
    • Germany
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    • Deutsche Sporthochschule Köln - Institut für Kreislaufforschung und Sportmedizin
    • Mr.  Lars  Hanke 
    • Am Sportpark Müngersdorf
    • 50933  Köln
    • Germany
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    • Deutsche Sporthochschule Köln - Institut für Kreislaufforschung und Sportmedizin
    • Mr.  Lars  Hanke 
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Sporthochschule Köln - Institut für Kreislaufforschung und Sportmedizin
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.