Clinical trial NCT01506310: Efficacy of Behavioral Therapy and Exercise in Gestational Diabetes Mellitus (GDM)
Official title: Randomized Comparative Trial on the Efficacy of Behavioral Therapy, Exercise and Their Combination in Gestational Diabetes Mellitus (GDM).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Birth-weight
Keywords: gestational diabetes mellitus
fasting glucose
insulin resistance
birth-weight
Glucose values
Insulin concentrations
Cesarean sections
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2012-01-10
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to test whether four lifestyle intervention programs (diet alone; diet and behavioral therapy, diet and exercise, diet and behavioral therapy and exercise), delivered to women with GDM during 24-26 weeks of gestational age will help women to improve their metabolic pattern, and decrease the incidence of adverse maternal and neonatal outcomes.

Detailed description: Women with gestational diabetes (GDM) are at increased risk of adverse pregnancy and neonatal outcomes. It is estimated that most women diagnosed with GDM can achieve targeted glycemic goals with nutrition therapy alone. A moderate exercise is recommended to lower serum glucose and to improve insulin sensitivity. Despite this, few reports examine the effect of exercise on glucose intolerance during pregnancy. Furthermore, no trial on the efficacy of behavioral treatment in women with GDM is available.

The purpose of the study is to test whether four lifestyle intervention programs (diet alone; diet and behavioral therapy, diet and exercise, diet and behavioral therapy and exercise), delivered to women with GDM during 24-26 weeks of gestational age will help women to improve their metabolic pattern, and decrease the incidence of adverse maternal and neonatal outcomes.

Eligibility criteria: Inclusion Criteria:

* Gestational age between 24 and 26 weeks
* Diagnosis of GDM at the 75g oral glucose tolerance test (OGTT)
* Singleton pregnancy

Exclusion Criteria:

* Body mass index \> 40 or \< 12kg/m2
* Any known diseases (pre-existing diabetes mellitus, cardiovascular diseases, liver/kidney diseases, cancers, arterial hypertension)
* Patients on any drugs

Primary outcomes:
measure: Serum fasting glucose values.
timeFrame: Fasting glucose will be measured at recruitment (24 weeks of gestation) and at the end of follow-up (38 weeks of gestation)
Secondary outcomes:
measure: Serum fasting insulin values
timeFrame: At recruitment (at 24 weeks of gestation) and at the end of follow-up (38 weeks of gestation)
measure: The need for insulin therapy
timeFrame: At recruitment and at the end of follow-up (38 weeks)
measure: The number of Cesarean sections
timeFrame: From recruitment until the date of delivery, either natural or by Caesarean section, assessed up to 42 weeks
measure: The mean birth-weight of newborns
timeFrame: From recruitment until the date of delivery, assessed up to 42 weeks
Other outcomes:
Locations:
city: Turin
country: Italy
facility: University of Turin
Study officials:
References:
citation: Bo S, Gambino R, Menato G, Canil S, Ponzo V, Pinach S, Durazzo M, Ghigo E, Cassader M, Musso G. Isoleucine-to-methionine substitution at residue 148 variant of PNPLA3 gene and metabolic outcomes in gestational diabetes. Am J Clin Nutr. 2015 Feb;101(2):310-8. doi: 10.3945/ajcn.114.095125. Epub 2014 Dec 17.