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Evaluation of Exercise, in Addition to Diet, in Women With Gestational Diabetes

1. juni 2017 oppdatert av: Michel Boulvain, University Hospital, Geneva
The main objective is to evaluate the effect of therapeutic exercise program on blood glucose regulation in women with gestational diabetes mellitus (GDM) who are assigned to diet-and-exercise, compared to diet only (usual treatment). The primary outcome is the need for insulin treatment in the two groups.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

In women with gestational diabetes, light to moderate daily physical activity may a useful therapeutic approach to improve the control of glycaemia and decrease the need for prescription of insulin. Increased physical activity in pregnant women with gestational diabetes is expected to decrease the mother and child morbidity associated with gestational diabetes, but also to improve the general health status of the mother and the child.

The objectives of this randomized trial are:

  • To evaluate the effect of therapeutic exercise program on blood glucose regulation in women with GDM who are assigned to diet-and-exercise protocol.
  • To demonstrate the feasibility of the therapeutic exercise treatment and the possibility of using the exercise program as an optional therapeutic approach for women with GDM.

Studietype

Intervensjonell

Registrering (Faktiske)

109

Fase

  • Ikke aktuelt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 50 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

Inclusion Criteria:

  • gestational diabetes, based on the criteria of Coustan-Carpenter, then on the International Association Diabetes Pregnancy Study Groups (IADPSG )

Exclusion Criteria:

  • pre-existing diabetes
  • twins

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Exercise + diet

Exercise intervention:

During the first session a standardized exercise prescription will be discussed with the participant. The exercise program will be of a moderate intensity, at less than 140 heart beats/min (which corresponds to 60% of the calculated maximum heart rate (HRmax) or 50% maximum oxygen volume (VO2max) ). A session of 30 to 60 minutes/week will be organised.

  • Participants will be instructed to conduct a nonsedentary lifestyle. They will be encouraged to increase their number of steps on a daily basis and perform not more that 45 minutes of continuous exercise per day. Pedometers will be used to measure the compliance and as a positive feedback for motivation.
  • The participants will return to the exercise laboratory once per week for Actiheart data downloading, number of steps recording, exercise support and counselling, and to perform the supervised group exercise intervention.

This is in addition to the diet (see below, control group)
Atferdsmessig: Exercise
Once per week, participants will be enrolled in supervised group exercise intervention. They will be encouraged in walking 45 minutes per day
Ingen inngripen: Diet only
Participants will receive diet counselling according to their characteristics. The usual recommendation is to have a fractioned normocaloric diet (unless the dietician identify a grossly hypercaloric diet), with low fat and increase in fibers content.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Prescription of insulin during the follow-up
Tidsramme: From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery, usually 38 to 41 weeks of gestation). It is impossible in our context to give a specific time point.
The primary outcome will include any amount (dosage) of insulin and any frequency of injection. Prescription of insulin is considered when glycaemia is above 5.3 mmol/L fasting and/or above 8.0 at 1 hour after the meal.
From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery, usually 38 to 41 weeks of gestation). It is impossible in our context to give a specific time point.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Control of glycemia
Tidsramme: From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery).
4 times per day, participants will check their blood sugar level. The investigators will record these blood sugar levels and consider as normal if below 5.3 mmol/L fasting and below 8.0 at 1 hour after the meal. Suboptimal glycemic control will be defined as 2 or more glycemia above these target values; good control will be defined as less than 2 values above the thresholds. The variable "good glycemic control" will be coded "yes" if the above criteria (<2 abnormal values) are met, and "no" otherwise (>=2 abnormal values)
From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery).
Compliance with the exercise (in the exercise group only)
Tidsramme: From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery).
Satisfactory compliance will be defined as walking at least 5000 steps/day 5 days a week and attending at 50% or more of the weekly supervised exercise program. The variable "compliance" will be coded "yes" if both the above criteria are met, and "no" otherwise
From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery).

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Timing of insulin treatment
Tidsramme: From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery).

To better understand the effect of the intervention on the primary outcome, prescription of insulin), the investigators will compare between groups:

Time between randomization and insulin prescription (days)
From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery).
Gestational age at start of insulin treatment
Tidsramme: From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery).
the investigators will compare between groups: Gestational age at start of insulin treatment (weeks) (mean ± SD)
From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery).
Dosage of long-acting insulin
Tidsramme: From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery).
Maximal dose of long-acting insulin per day (mean ± SD)
From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery).
Dosage of short-acting insulin
Tidsramme: usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery).
Maximal dose of short-acting insulin per day (mean ± SD)
usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery).

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University Hospital, Geneva

Etterforskere

  • Hovedetterforsker: Michel Boulvain, Hôpitaux Universitaires de Genève

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

21. februar 2008

Primær fullføring (Faktiske)

25. april 2013

Studiet fullført (Faktiske)

19. juni 2013

Datoer for studieregistrering

Først innsendt

24. januar 2017

Først innsendt som oppfylte QC-kriteriene

1. juni 2017

Først lagt ut (Faktiske)

2. juni 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. juni 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. juni 2017

Sist bekreftet

1. juni 2017

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 07-080 MATPED 07-021

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Meta-analysis with the Cochrane Collaboration, if individual patient data are needed

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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