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临床试验/ACTRN12617000659303
ACTRN12617000659303已完成未知

The effect of high carbohydrate and low carbohydrate suppers on fasting blood glucose levels (BGLs) in gestational diabetes mellitus (GDM)

Dr Dorothy Graham0 个研究点目标入组 69 人开始时间: 2017年5月8日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
69

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 50 Years(—)
性别
Female

入选标准

  • aHave gestational diabetes diagnosed on routine oral glucose tolerance test. OGTT will diagnose gestational diabetes if fasting BSL is greater than or equal to 5.1, 1 hour reading is greater than or equal to 10, 2 hours greater than or equal to 8.5.
  • bBe on diet control (no oral hypoglycaemic agents or insulin)
  • cHave two or more fasting BGLs of 4.7-5.4mmol/L in the week prior to recruitment
  • dHave a singleton pregnancy
  • eAre between 24 and 34 weeks gestation
  • fHave not had hospital admissions or Celestone therapy for the 2 weeks of the study
  • gHave no food allergies or intolerances that preclude them taking the snack
  • hAre compliant with BGL monitoring
  • iFasting BGL recorded between 6am to 8am with a minimum time of 8 hours since their evening snack
  • jAre capable of giving informed consent
  • kAre women aged greater than or equal to 18 years of age
  • lHave dinner between the hours of 5pm and 8 pm, with a 2 hour minimum time between evening meal and evening snack

排除标准

  • aRequiring NovoRapid (fast acting insulin) with meals or requiring Protaphane (long acting insulin) during the two week period (as per treating physician’s decision)
  • bPatients on metformin or other medications which may affect glucose metabolism (as per treating physician’s decision) during the study
  • cShift workers, or irregular meal times for any other reason
  • dgreater than or equal to 3 fasting BGLs greater or equal to 5.2mmol/L in the week prior to recruitment
  • eMacrosomic foetus, defined as AC greater than 90 percentile or polyhydramnios
  • fWomen who require an interpreting service
  • gWomen who have had bariatric surgery

研究者

发起方
Dr Dorothy Graham

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