Diabetes mellitus and abnormal glucose tolerance development after gestational diabetes

ISRCTN	ISRCTN24165302
DOI	https://doi.org/10.1186/ISRCTN24165302
Protocol serial number	N/A
Sponsor	St Carlos Hospital (Hospital Clínico San Carlos) (Spain)
Funder	Ministry of Health (Spain) - Cohesion Funds 2006

Submission date: 11/05/2009
Registration date: 29/05/2009
Last edited: 30/09/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Alfonso Calle Pascual
Scientific

Endocrinology and Nutrition Department
St Carlos Hospital (Hospital Clinico San Carlos)
Martin Lagos S/N
Madrid
28040
Spain

Phone	+34 91 33 03 281
Email	acalle.hcsc@salud.madrid.org

Study information

Primary study design	Interventional
Study design	Single-centre clinic-based prospective randomised interventional study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Diabetes mellitus and abnormal glucose tolerance development after gestational diabetes: a 3-year, prospective, randomised, clinic-based, interventional study with parallel groups
Study acronym	DIATAGEST
Study objectives	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(s)	St Carlos Hospital Ethics Committee, 19/01/2007
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	31/12/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	250
Key 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
Key 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
Date of first enrolment	01/01/2006
Date of final enrolment	31/12/2010

Locations

Countries of recruitment

Spain

Study participating centre

Endocrinology and Nutrition Department

Madrid
28040
Spain

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2015		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes