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 measure
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 (if study stopped)
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
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25262459
Publication citations
-
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.