Condition category
Nutritional, Metabolic, Endocrine
Date applied
11/05/2009
Date assigned
29/05/2009
Last edited
30/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Alfonso Calle Pascual

ORCID ID

Contact details

Endocrinology and Nutrition Department
St Carlos Hospital (Hospital Clinico San Carlos)
Martin Lagos S/N
Madrid
28040
Spain
+34 91 33 03 281
acalle.hcsc@salud.madrid.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Diabetes mellitus and abnormal glucose tolerance development after gestational diabetes: a 3-year, prospective, randomised, clinic-based, interventional study with parallel groups

Acronym

DIATAGEST

Study hypothesis

It is well established that gestational diabetes confers a substantial risk of development diabetes and glucose intolerance. Accumulated incidence rates of diabetes mellitus in these women vary among different studies, being up to 50% in 5 years, with lower incidence in Caucasian populations. In addition, these women present higher rates of risk factors for cardiovascular disease and metabolic syndrome, including smoking status, hypertension, dyslipidaemia, central obesity, insulin resistance and abnormalities in vascular endothelium and microalbuminuria. We assumed that women had normal glucose values (less than 100 mg/dl) between 6 - 12 weeks after delivery and progressed to diabetes after oral glucose tolerance test (OGTT) at 2% per year and greater than 10% per year for impaired fasting glucose (IFG) or impaired glucose tolerance (IGT). Lifestyle intervention has been associated with a reduction in diabetes and glucose intolerant progression, but this remains to be proven in a real world situation.

The study hypothesis is to assess the reduction in the conversion to abnormal glucose tolerance (IFG and IGT), and type 2 diabetes after a lifestyle and exercise supervised-based programme, compared to standard treatment, in women attended in Area 7, Madrid who were diagnosed with gestational diabetes (GDM) by Couston and Carpenter criteria and normal glucose tolerance between 6 and 12 weeks after delivery.

Ethics approval

St Carlos Hospital Ethics Committee, 19/01/2007

Study design

Single-centre clinic-based prospective randomised interventional study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Gestational diabetes/diabetes mellitus prevention

Intervention

Eligible women with normal fasting plasma glucose values between 6 and 12 weeks after delivery were randomly assigned to receive:
1. Standard treatment: 1 hour education session and follow up by family physicians at primary care level
2. A lifestyle, exercise-supervised intervention programme
Adjustments were made for age, body mass index, use of insulin during gestation and ethnic origin.

Lifestyle exercise-supervised programme was performed during 8 weeks in the Rehabilitation Unit at the St Carlos University Hospital between 3 and 6 months after delivery and reinforced during 1 hour sessions at the end of the supervised period, 3 and 6 months later.

The supervised physical activity programme consisted in a combined supervised aerobic and resistance training of 50 - 60 minutes per session, four days a week: two days at the hospital and other two days at home, for eight weeks. The physical activity included a proper warm-up and cool-down period, 20 minutes of cycling at moderate intensity and 20 minutes resistance training with 3 sets ranging from 10 repetitions, for all main muscle groups. In addition, all patients were encouraged to increase daily physical activities, mainly brisk walking and climbing stairs.

Nutrition interventions were performed in a 2 hour session aimed to achieve a lifestyle score greater than 12 based on Diabetes Nutrition and Complications Trial (DNCT) previously reported.

Women will be follow-up yearly during 3 years with an OGTT with 75 g, and insulin and cytokines plasma values, body weight, waist circumference and blood pressure values will be performed.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Estimation of the conversion rate to abnormal glucose tolerance (type 2 diabetes mellitus, IFG and IGT) of women with prior gestational diabetes mellitus (GDM) and normal fasting glucose values after delivery, measured yearly.

Secondary outcome measures

Estimation of the changes in:
1. HbA1c
2. Insulin
3. Homestatic model assessment (HOMA)
4. Total (high density lipoprotein [HDL] and low density lipoprotein [LDL]) cholesterol
5. Triglycerides
6. Apolipoprotein B
7. Cytokines
8. Body weight
9. Waist circumference
10. Blood pressure
11. Adherence to changes in lifestyle

All outcomes are measured yearly.

Overall trial start date

01/01/2006

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women diagnosed with gestational diabetes mellitus between 24 and 28 weeks of gestation by Couston and Carpenter criteria between January 2006 and December 2007
2. Normal fasting glucose values (less than 100 mg/dl) between 8 - 12 weeks after delivery

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

250

Participant exclusion criteria

1. Fasting glucose level greater than 100 mg/dl between 8 - 12 weeks after delivery
2. New gestation during 3-years follow-up

Recruitment start date

01/01/2006

Recruitment end date

31/12/2010

Locations

Countries of recruitment

Spain

Trial participating centre

Endocrinology and Nutrition Department
Madrid
28040
Spain

Sponsor information

Organisation

St Carlos Hospital (Hospital Clínico San Carlos) (Spain)

Sponsor details

c/o Alfonso Calle Pascual
Endocrinology and Nutrition Department
Martin Lagos S/N
Madrid
28040
Spain
+34 91 33 03 281
acalle.hcsc@salud.madrid.org

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Ministry of Health (Spain) - Cohesion Funds 2006

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25262459

Publication citations

  1. Results

    Pérez-Ferre N, Del Valle L, Torrejón MJ, Barca I, Calvo MI, Matía P, Rubio MA, Calle-Pascual AL, Diabetes mellitus and abnormal glucose tolerance development after gestational diabetes: A three-year, prospective, randomized, clinical-based, Mediterranean lifestyle interventional study with parallel groups., Clin Nutr, 2014, doi: 10.1016/j.clnu.2014.09.005.

Additional files

Editorial Notes