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

NCT03174340 | Completed

• 1 other identifier: 07-080 MATPED 07-021
• Study Type: interventional
• Target: 109
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Gestational Diabetes

Outcome Measures

Primary Outcomes (1)

• Prescription of insulin during the follow-up

  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.

Secondary Outcomes (2)

• Control of glycemia

  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)

  From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery).

Other Outcomes (4)

• Timing of insulin treatment

  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

  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

  From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery).

Study Arms (2)

Exercise + diet

EXPERIMENTAL

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)

Behavioral: Exercise

Diet only

NO INTERVENTION

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.

Interventions

Exercise BEHAVIORAL

Once per week, participants will be enrolled in supervised group exercise intervention. They will be encouraged in walking 45 minutes per day

Exercise + diet

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• pre-existing diabetes
• twins

Sponsors & Collaborators

• University Hospital, Geneva: lead

Related Publications (1)

• Boulvain M, Othenin-Girard V, Jornayvaz FR, Kayser B. Impact of an exercise program combined with dietary advice on avoiding insulin prescription in women with gestational diabetes: a randomized controlled trial. Diabetol Metab Syndr. 2024 Sep 30;16(1):238. doi: 10.1186/s13098-024-01470-1.

  PMID: 39343942 DERIVED

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Michel Boulvain

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 24, 2017
• First Posted: June 2, 2017
• Study Start: February 21, 2008
• Primary Completion: April 25, 2013
• Study Completion: June 19, 2013
• Last Updated: June 2, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share