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

1 juni 2017 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

109

Fas

  • Inte tillämpbar

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 50 år (Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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)
Beteende: Exercise
Once per week, participants will be enrolled in supervised group exercise intervention. They will be encouraged in walking 45 minutes per day
Inget ingripande: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Prescription of insulin during the follow-up
Tidsram: 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.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Control of glycemia
Tidsram: 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)
Tidsram: 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).

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Timing of insulin treatment
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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).

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University Hospital, Geneva

Utredare

  • Huvudutredare: Michel Boulvain, Hôpitaux Universitaires de Genève

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

21 februari 2008

Primärt slutförande (Faktisk)

25 april 2013

Avslutad studie (Faktisk)

19 juni 2013

Studieregistreringsdatum

Först inskickad

24 januari 2017

Först inskickad som uppfyllde QC-kriterierna

1 juni 2017

Första postat (Faktisk)

2 juni 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

2 juni 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

1 juni 2017

Senast verifierad

1 juni 2017

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 07-080 MATPED 07-021

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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