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

1. juni 2017 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

109

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 50 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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)
Adfærdsmæssigt: Exercise
Once per week, participants will be enrolled in supervised group exercise intervention. They will be encouraged in walking 45 minutes per day
Ingen indgriben: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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).

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Hospital, Geneva

Efterforskere

  • Ledende efterforsker: Michel Boulvain, Hopitaux Universitaires de Geneve

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

21. februar 2008

Primær færdiggørelse (Faktiske)

25. april 2013

Studieafslutning (Faktiske)

19. juni 2013

Datoer for studieregistrering

Først indsendt

24. januar 2017

Først indsendt, der opfyldte QC-kriterier

1. juni 2017

Først opslået (Faktiske)

2. juni 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juni 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. juni 2017

Sidst verificeret

1. juni 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 07-080 MATPED 07-021

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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

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