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临床试验/NCT03592784
NCT03592784终止不适用

Carbohydrate-Last Food Order Intervention for Gestational Diabetes Mellitus

Weill Medical College of Cornell University1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2018年6月18日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
28
试验地点
1
主要终点
Feasibility of the Food Order Intervention

研究概览

简要总结

This is a randomized controlled feasibility trial for women diagnosed with gestational diabetes mellitus (GDM). The current front-line treatment for GDM is medical nutrition therapy (MNT), i.e. personalized diets which may or may not include mild carbohydrate restriction. Use of carbohydrate restriction increases the risk of the mother developing ketosis, a harmful condition for both the mother and fetus. If MNT is not enough to stabilize blood sugar levels, then pharmaceuticals are prescribed. In patients with type-2 diabetes and prediabetes, the carbohydrate-last food order behavior has been shown to improve post-meal blood sugar control without the need of reduced carbohydrate intake. Given this data, the addition of this intervention to MNT in patients with GDM may be helpful in achieving controlled blood sugar levels without increasing the risk of ketosis. This study will include two randomized groups diagnosed with GDM. Patients in the control group will be prescribed standard MNT. Patients in the intervention group will have identical MNT but with additional food order instruction/therapy. All patients will be followed up with at 1-2 week intervals. At each follow-up the physician and dietician will analyze the patient's blood sugar measurements and, among additional factors, determine if pharmaceuticals should be added. Treatment will continue through delivery. The primary aim of this study is to assess the feasibility of the carbohydrate last food order in GDM and generate preliminary data on its effects on glucose control.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant subjects ≥18 years old
  • Newly diagnosed with GDM between 24-32 weeks of gestation with at least 2 days of self-monitored glucose logs or diagnosed via a 50g glucose challenge test (GCT) greater than 200mg/dL

排除标准

  • Pre-existing diabetes prior to conception
  • Patients whom do not plan on consuming at least 3 meals daily throughout gestation (e.g. during Ramadan)
  • Requirement of special medical diet (e.g. from phenylketonuria, celiac disease, etc.)
  • History of bariatric surgery

结局指标

主要结局

Feasibility of the Food Order Intervention

时间窗: 8 weeks

Measured via feasibility questionnaire.

次要结局

  • Average 1-hour postprandial glucose(2, 4, 6, 8, 10, 12 weeks)
  • Time to initiation of pharmacotherapy(2, 4, 6, 8, 10, 12 weeks)
  • Proportion of patients requiring the addition of pharmacotherapy(Week 16 or End of study (at delivery))
  • Birthweight(Week 16 or End of study (delivery))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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