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临床试验/NCT05132725
NCT05132725Unknown不适用

Studying the Effect of Gluten Free Diet Alone Versus Combination of Gluten Free Diet With Either Carbohydrate Count or Dietary Approach to Reduce Hypertension Diet on Their Glycemic Control, Growth Rate and Quality of Life Among Children With Type 1 Diabetes Mellitus and Celiac Disease

University of Jordan1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2021年11月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
45
试验地点
1
主要终点
HbA1c

研究概览

简要总结

Study is an interventional clinical trial. children (aged 6-18 years) diagnosed with type 1 diabetes and celiac disease will be recruited conveniently from Endocrinology pediatric clinic at Prince Hamzah Hospital. Amman, Jordan. A sample of 45 diagnosed children, who will meet the inclusion criteria and will be agreed to participate will be centrally randomized to follow carbohydrate counting with GFD dietary intervention, carbohydrate counting with GFD and DASH dietary intervention, and control dietary intervention.

详细描述

the main objective of this study to compare the effects of three diets: carbohydrate count with gluten-free diet, DASH and carbohydrate count with gluten-free diet, and gluten-free diet alone on glycemic control, growth rate, and the quality of life of 45 individual patients diagnosed with diabetes and celiac disease, who are receiving care in Prince Hamzah Hospital, and aged between 6-18 years, will be enrolled in this study. the duration of the follow-up will be up to ( 9 months); starting from the first interview and enrollment till reaching 9 months from the intervention. all the biochemical tests that are routinely measured will be recorded for each patients during the follow-up duration. these biochemical tests will be, mainly hemoglobin A1C, serum glucose, tissue-trans glutamines IgA( TTG IgA), vitamin D, calcium, phosphorus, and acute intermittent porphyria ( AIP) and will be recorded at baseline, after 6 months and at the end of the study (12 months). growth rate, and quality of life will be also assessed at based line, after 6 months and at the end of the study.

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
Single (Outcomes Assessor)

入排标准

年龄范围
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 1- Jordanian children aged between 6 to 18 years old . 2- diagnosed with diabetes type 1 and celiac disease together. -

排除标准

  • 1- any children diagnosed with celiac disease alone. 2- any children diagnosed with type 1 diabetes alone. 3- any children with different disease.

结局指标

主要结局

HbA1c

时间窗: one year

Hemoglobin A1c% at both baseline and endline of intervention

glucose serum

时间窗: one year

fasting blood glucose% at both baseline and endline of intervention.

TTG-IgA

时间窗: one year

TTG-IgA% \\ at both and endline of intervention.

次要结局

  • Weekly weight gain(one year)
  • height(one year)
  • BMI(one year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marah Al Majali

student

University of Jordan

研究点 (1)

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