Trial document





This trial has been registered retrospectively.
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  DRKS00000465

Trial Description

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Title

MuKiS - mother-child-sports - a study to evaluate the impact of exercise on maternal metabolism and fetal development in women with gestational diabetes

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The number of pregnant women with gestational diabetes is increasing worldwide. Increased maternal and fetal morbidity and an increased long-term risk for obesity and type 2 diabetes are a direct consequence. There are hardly any studies on the influence of movement on the child's metabolic status and child development in the womb. MuKiS (mother-child-sport) is a pilot study and examines the feasibility and the efficiency of a movement therapy in women with gestational diabetes. 60 women with gestational diabetes should be included in the study. These must be between 24th and 30th week of pregnancy. The women are then randomized into an intervention and control group (n = 30 n = 30). Women in the intervention group received 10 weeks physical activity. The physical activity programm takes place two times a week for 45 minutes instead. If a positive influence on movement by the mother's metabolic status and child development are shown by MuKiS, so in a subsequent study, the efficiency and durability of this lifestyle intervention in a Phase II-III study will be evaluated.

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Brief Summary in Scientific Language

The number of pregnant women with gestational diabetes is increasing worldwide. Increased maternal and fetal morbidity and an increased long-term risk for obesity and type 2 diabetes are a direct consequence. There are hardly any studies on the influence of movement on the maternal metabolic control and children's development. MuKiS (mother-child-sport) is a pilot study and examines the feasibility and the efficiency of a movement therapy in women with gestational diabetes. 60 women with gestational diabetes should be included in the study. These must be between 24th and 30th week of pregnancy. The women are then randomized into an intervention or control group (n=30 /n=30). Women in the intervention group received 10 weeks physical activity. The physical activity programm takes place two times a week for 45 minutes instead. The feasibility of the study will be evaluated on the basis number of achieved sports units, including the numbers of enrolled patients and socio-demographic factors. The effectiveness of exercise therapy is determined on the basis of exploratory maternal resting heart rate, parameters of the fetal ultrasound, birth weight and postnatal body fat composition, and various biomarkers. If a positive influence on movement through the maternal metabolic control and children's development are shown by MuKiS, so in a subsequent study the efficiency and sustainability to this lifestyle intervention will be evaluated in a phase II-III study.

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Organizational Data

  •   DRKS00000465
  •   2010/06/30
  •   [---]*
  •   yes
  •   Approved
  •   2133/08, Ethik-Kommission der Fakultät für Medizin der Technischen Universität München
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Secondary IDs

  •   U1111-1115-6802 
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Health Condition or Problem studied

  •   O24.4 -  Diabetes mellitus arising in pregnancy
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Interventions/Observational Groups

  •   physical activity intervention: under professional supervision, two times a week, 45 minutes, heart rate, alternately walking and bicycle ergometry.
    Nutrition: Diet therapy according to the dietary recommendations of the German Nutrition Society (DGE) and the German Diabetes Society (DDG)
  •   physical activity: no.
    Nutrition: diet therapy after the dietary recommendations of the German Nutrition Society (DGE) and the German Diabetes Society (DDG)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Prevention
  •   Parallel
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Primary Outcome

The present project should investigate, if maternal metabolism and child development get positively influenced by increasing physical activity during pregnancy in women with gestational diabetes. The project is carried out first as a pilot study in 60 women. When all 60 women are recruited, in about two years, the evaluation will begin. At the same time should also be assessed the feasibility of a sports intervention in this patient population.
Target parameters for a viable and successful sports intervention are:
1) High participation rates and compliance, regardless of nationality and social factors
2) to increase the well-being and spontaneous physical activity (mood questionnaire: Visit 0: 29-30. pregnancy week, Visit 1: 38-39 pregnancy week, Visit 3: 4 weeks postpartum)
3) improving the performance / handling of pregnant women (reduction of resting heart rate, cycle ergometer test according to WHO criteria, measurement of heart rate, Visit 0: 29-30. week of pregnancy, Visit 3: 4 weeks postpartum)
4) Change of maternal biomarkers by sports Intervention (adipokines, metabolomics, insulin resistance, breath Profile: Visit 0: 29./30. week of pregnancy, Visit 1: 38./39. week of pregnancy, Visit 3: 4 Wochen postpartum)
5) normalization of the fetal abdominal circumference, lower rate of polyhydramnios and Sectioraten, and normalization of birth weight (Fetal Ultrasound Visit 0: 29./30. week of pregnancy. Ultrasound of the child. Visit 2: 4 weeks postpartum)
6) Reduced rate of prenatal fetal macrosomia and cardiac hypertrophy
7) Lower postnatal rate of macrosomia and cardiac hypertrophy.

In summary: The aim of the physical activity is to improve performance, and to obtain a positive effect on childbirth. We also assume that the physical activity of the mother has an effect on the development of the child. One of the main goals is the long-term mothers to a lifestyle change to move that through healthy diets and increased physical activity will affect the whole family. The sustainability of the operation will be evaluated on successful pilot study with a larger intervention study, which provides for a follow-up postpartum. On the side of the child we hope by improving the intrauterine environment risks such as cardiac changes, macrosomia to the child and polyhydramnios can be prevented.

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2009/05/29
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   24   Weeks of pregnancy
  •   30   Weeks of pregnancy
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Additional Inclusion Criteria

Women who are diagnosed with gestational diabetes (gestational diabetes according to the guidelines of the AG Diabetes and pregnancy DDG 2003),
• confinement during the 24th and 30th Week of pregnancy
• > 18 years of age
• Written permission

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Exclusion Criteria

• disease of the heart, circulatory or kidney
• Arterial hypertension or hypertensive disease of pregnancy
• multiple pregnancy
• Acute systemic diseases or infections
• cervical incompetence, cerclage
• Premature labor in current pregnancy
• placenta praevia after the 26th Week of pregnancy
• contraindications, which do not permit participation in moderate physical activity

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinikum rechts der Isar der TU München Forschergruppe Diabetes der TU München
    • Ms.  Prof. Dr. med.  Anette-Gabriele  Ziegler 
    • Kölner Platz 1
    • 80804  München
    • Germany
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    •   089-31872896
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    • Klinikum rechts der Isar der TU München Forschergruppe Diabetes der TU München
    • Ms.  Prof. Dr. med.  Anette-Gabriele  Ziegler 
    • Kölner Platz 1
    • 80804  München
    • Germany
    end of 1:1-Block address scientific-contact
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    • Klinikum rechts der Isar der TU München Forschergruppe Diabetes der TU München
    • Ms.  Dipl. Sportwiss.   Lydia  Henneberger 
    • Kölner Platz 1
    • 80804  München
    • Germany
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Sources of Monetary or Material Support

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    • Klinikum rechts der Isar der TU München Forschergruppe Diabetes der TU München
    • Ms.  Prof. Dr. med.  Anette-Gabriele  Ziegler 
    • Kölner Platz 1
    • 80804  München
    • Germany
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    •   089-31874194
    •   [---]*
    •   [---]*
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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.