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
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
- 否
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.
研究组 & 干预措施
Dietary intervention CHO counting combined with GFD
Carbohydrate counting diet will be prepared according to Kulkarni, (2005). Tailored diet plans according to patient's food preference, physical activity level and appropriate insulin: Carbohydrates ratio will be prescribed for each participants. Diets were based on each participants' recommended intakes of energy, protein (15-25%), fat (30-40%) and carbohydrate (40-50%) (Thomas and Gutierrez, 2005; Kleinwechter et al., 2014). Energy requirement will be determined in the participants' weight. The carbohydrate counts will be distributed into three main meals and 3 snacks, with the general dietary advice and diet that will be prescribed by hospital for participants
干预措施: diet therapy (Behavioral)
Dietary intervention CHO Counting with GFD & DASH
The recommended intakes of energy, protein (15-25%), fat (30-40%) and carbohydrate (40-50%) will be similar to that in carbohydrate counting diet which mentioned above. DASH diet food choices will be inserted in the diet of the participants assigned for the combined diet of DASH and carbohydrate counting. The emphasis will be more on the fruits and vegetables group (>8 servings/day), whole grains (at least half of the amount of the total servings of cereals; 6-8 servings/day), fat free dairy products (2-3 servings/day), lean meat and plant proteins (0-2 servings/day) and nuts (5-7 servings/week). From the fat group olive oil will represent the main type of fat (20-25% of total fat %). Adequate intake of sodium (2000mg) will be applied into participants' diet, with the general dietary advice and diet that will be prescribed by hospital for participants
干预措施: diet therapy (Behavioral)
General Dietary guidlines
the general dietary advice and diet that will be prescribed by hospital for participants
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
Marah Al Majali
student
University of Jordan