Overweight Clinical Trial
Official title:
Low Glycemic Index Diet Intervention on Insulin Resistance of Overweight Pregnant Women.
Verified date | August 2016 |
Source | Children's Hospital of Fudan University |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Ministry of Health |
Study type | Interventional |
The study is a randomized, single-blinded, controlled intervention trial to compare the effect of a low glycemic index diet versus diet recommended by the Chinese Dietary Guide for Pregnant Women on maternal and neonatal insulin resistance and adverse gestational events.
Status | Completed |
Enrollment | 400 |
Est. completion date | March 2016 |
Est. primary completion date | February 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion - Singleton pregnancy; - Pregnant women with BMI=24 kg/m2 at first antenatal examination; - aged 18 years to 45 years; - The week of first prenatal examination equal to or less than 12 weeks; - Take routine prenatal examination; - Willing and able to give informed consent. Exclusion - Artificial impregnation; - History of hypertension, diabetes, coronary heart disease or mental disorder; - With Special diet habit(e.g. vegetarianism/ veganism). |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
China | Kunshan Maternal and Child Health Care Hospital | Kunshan city | Jiangsu |
China | International Peace Maternity and Child Care Centers of Communications University | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital of Fudan University | Kunshan City Maternal and Child Health, Shanghai Jiao Tong University School of Medicine |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maternal insulin resistance | During pregnancy | No | |
Primary | Cord blood C-peptide | at delivery | No | |
Primary | Maternal weight gain | measured before delivery (minus pre-conceptual body weight) | measured before delivery | No |
Primary | Incidence of gestational diabetes | from 1st antenatal visit to delivery | during pregnancy | No |
Primary | Incidence of macrosomia | birth weight >= 4000g | at delivery | No |
Secondary | Incidence of gestational hypertension | proportion of patients with SBP/SBP>=140/90 for 3 visits | during pregnancy | No |
Secondary | Mean infant birth weight | at delivery | No | |
Secondary | cesarean | at delivery | No | |
Secondary | head circumference | at delivery | No | |
Secondary | Mean gestational age | at delivery | No | |
Secondary | Incidence of premature delivery | gestational age <37 week at delivery | at delivery | No |
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