Carbohydrate Counting and DASH Intervention and Pregnancy Outcomes Among Women With Gestational Diabetes
2018年11月21日 更新者：Sabika Salem Allehdan、University of Jordan
Studying the Effectiveness of Carbohydrate Counting and Dietary Approach to Stop Hypertension Dietary Intervention on Glycemic Control and Maternal and Newborn Health Outcomes Among Jordanian Pregnant Women With Gestational Diabetes
Study is an interventional clinical trial.
Pregnant women (aged 25-40 years) diagnosed with GDM (by a 75-g oral glucose tolerance test at 24-28 weeks' gestation) will be recruited conveniently from Obstetrics and Gynecology clinic at the Jordan University Hospital and National Center for Diabetes, Endocrinology and Genetics, Amman, Jordan.
A sample of 180 pregnant women with GDM (60 women who do not use insulin and hypoglycemia medications, 60 women who are treated with metformin, 60 women who are treated with insulin), who will meet the inclusion criteria and will be agreed to participate will be centrally randomized to follow carbohydrate counting dietary intervention, carbohydrate counting and DASH dietary intervention, and control dietary intervention.
研究概览
详细说明
The main objective of this study is to compare the effect of carbohydrate counting, carbohydrate counting and DASH diet dietary interventions and a general dietary intervention on glycemic control, maternal and neonatal outcomes among Jordanian pregnant women with GDM.
Eligibility criteria to be enrolled in the study will be being Jordanian pregnant women with GDM at 24 -28 gestational weeks, aged between 25 to 40 with no-personal history of type 1 or 2 diabetes, or impaired fasting glucose, or chronic diseases and singleton gestation.
DASH diet; and the third group will follow the diet prescribed by the hospital for GDM.
The duration of intervention will extend from 24-28 gestational weeks until delivery, which will be usually 12-14 weeks later.
The glycemic controls outcomes are testing fasting blood glucose, HbA1C, insulin and fructosamine at baseline and at end of intervention for three dietary interventions.
While maternal outcomes are total maternal weight gain (kg), need for emergency caesarean section, the presence or absence of pregnancy-induced hypertension and preeclampsia.
The new born birth weight, length and head circumference, the presence or absence of hypoglycemia and shoulder dystocia are the newborn outcomes.
研究类型
介入性
注册 (预期的)
180
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Amman、约旦、009626
- 招聘中
- Sabika Allehdan
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接触：
- Sabika Allehdan, MSc
- 电话号码：799232789
- 邮箱：sabika_1986@Yahoo.com
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
25年 至 40年 (成人)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- Jordanian pregnant women with GDM at 24 -28 gestational weeks.
- Aged 25-40 with no-personal history of type 1 or 2 diabetes, or impaired fasting glucose (Koivusalo et al., 2016).
- Singleton gestation (Louie et al., 2011).
- Absence of chronic diseases such as hypertension, hepatic and kidney disease and cancer, and psychiatric disorder (Ma et al., 2014).
- Absence of the use of medication that influences glucose metabolism, such as continuous therapy with oral corticosteroids (Koivusalo et al., 2016)
- Pregnant women who do not have special dietary requirements (Louie et al., 2011).
Nonsmoker or nonalcoholic drinker during pregnancy (Louie et al., 2011) Well educated and well cooperative, more than 10 years of formal schooling (Ma et al., 2014).
Exclusion Criteria:
- Non- Jordanian pregnant women or Jordanian pregnant women with GDM at <24 or >28 gestational weeks.
- Aged > 40 years with multiple gestation and suspected over-diabetes (Koivusalo et al., 2016).
- Multiple gestations (Louie et al., 2011).
- Presence of chronic diseases, severe psychiatric disorder. Women with the risk factors for placental insufficiency, or history of preeclampsia (Ma et al., 2014; Koivusalo et al., 2016).
- Presence of the use of medication that influences glucose metabolism, such as continuous therapy with oral corticosteroids (Koivusalo et al., 2016)
- Pregnant women who have special dietary requirements (Louie et al., 2011).
- Who smoked or consumed alcohol during pregnancy (Louie et al., 2011)
- Less than 10 years of formal schooling or previous intensive nutrition education or intervention for diabetes (Ma et al., 2014).
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Dietary intervention CHO counting
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's 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' pre-pregnancy weight with adding the extra requirement (450 kcal) due to pregnancy.
The carbohydrate counts will be distributed into three main meals and 3 snacks.
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Adjusting the quantity and quality of food intake to improve glycemic control, maternal and newborn health outcomes of women with gestational diabetes.
其他名称：
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实验性的：Dietary intervention CHO Counting & 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.
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Adjusting the quantity and quality of food intake to improve glycemic control, maternal and newborn health outcomes of women with gestational diabetes.
其他名称：
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无干预：General Dietary guidlines
the general dietary advice and diet that will be prescribed by hospital for participants
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Fasting blood glucose
大体时间：one year
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Fasting blood glucose in mg/dL at 24 -28 weeks of gestation (baseline) and at 36-37) weeks of gestation(endline) of intervention.
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one year
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Hemoglobin A1c level
大体时间：one year
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Hemoglobin A1c% at both baseline and endline of intervention
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one year
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Fasting insulin level
大体时间：one year
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Fasting insulin level in µIU/mL at both baseline and endline of intervention.
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one year
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Fructosamine level
大体时间：one year
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fructosamine in µmol/L at both baseline and endline of intervention.
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one year
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Total maternal weight gain
大体时间：one year
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Total maternal weight gain during pregnancy in kilograms
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one year
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Weekly weight gain
大体时间：one year
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weight in kilogram will be measured weekly for all participants
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one year
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Insulin Therapy
大体时间：one year
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Number of participants who need insulin therapy to normalize blood sugar.
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one year
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Emergency caesarean section
大体时间：one year
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Number of participants who need for emergency caesarean section versus vaginal delivery.
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one year
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Pregnancy-induced hypertension
大体时间：one year
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Number of participants with existence of hypertension (defined as a blood pressure of at least 140/90 mmHg on two occasions).
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one year
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Newborn weight
大体时间：one year
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The newborn weight in grams
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one year
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Newborn Length
大体时间：one year
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The new born length in centimeters.
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one year
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Newborn head circumference
大体时间：one year
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The newborn head circumference in centimeters.
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one year
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Hypoglycemic
大体时间：one year
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Number of newborn babies who will suffer from hypoglycemia
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one year
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Shoulder dystocia
大体时间：one year
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Number of newborn babies with shoulder dystocia.
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one year
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Reema F Tayyem, PhD、University of Jordan
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Kulkarni DK. Carbohydrate counting: A practical meal-planning option for people with diabetes. Clinical Diabetes 23:120-22, 2005.
- Koivusalo SB, Rono K, Klemetti MM, Roine RP, Lindstrom J, Erkkola M, Kaaja RJ, Poyhonen-Alho M, Tiitinen A, Huvinen E, Andersson S, Laivuori H, Valkama A, Meinila J, Kautiainen H, Eriksson JG, Stach-Lempinen B. Erratum. Gestational Diabetes Mellitus Can Be Prevented by Lifestyle Intervention: The Finnish Gestational Diabetes Prevention Study (RADIEL). A Randomized Controlled Trial. Diabetes Care 2016;39:24-30. Diabetes Care. 2017 Aug;40(8):1133. doi: 10.2337/dc17-er08a. Epub 2017 Jun 14. No abstract available.
- Ma WJ, Huang ZH, Huang BX, Qi BH, Zhang YJ, Xiao BX, Li YH, Chen L, Zhu HL. Intensive low-glycaemic-load dietary intervention for the management of glycaemia and serum lipids among women with gestational diabetes: a randomized control trial. Public Health Nutr. 2015 Jun;18(8):1506-13. doi: 10.1017/S1368980014001992. Epub 2014 Sep 15.
- Louie JC, Markovic TP, Perera N, Foote D, Petocz P, Ross GP, Brand-Miller JC. A randomized controlled trial investigating the effects of a low-glycemic index diet on pregnancy outcomes in gestational diabetes mellitus. Diabetes Care. 2011 Nov;34(11):2341-6. doi: 10.2337/dc11-0985. Epub 2011 Sep 6.
- Thomas, A. M. and Gutierrez, Y.M. (2005), American Dietetic Association guide to gestational diabetes mellitus. Chicago, IL: American Dietetic Association. Received from http://www.eatright.org/Public/ProductCatalog/ SearchableProducts/104_20728.cfm. Accessed 23 January 2016.
- Kleinwechter H, Schafer-Graf U, Buhrer C, Hoesli I, Kainer F, Kautzky-Willer A, Pawlowski B, Schunck K, Somville T, Sorger M; German Diabetes Association; German Association for Gynaecology and Obstetrics. Gestational diabetes mellitus (GDM) diagnosis, therapy and follow-up care: Practice Guideline of the German Diabetes Association(DDG) and the German Association for Gynaecologyand Obstetrics (DGGG). Exp Clin Endocrinol Diabetes. 2014 Jul;122(7):395-405. doi: 10.1055/s-0034-1366412. Epub 2014 Jul 11. No abstract available.
- Allehdan S, Basha A, Hyassat D, Nabhan M, Qasrawi H, Tayyem R. Effectiveness of carbohydrate counting and Dietary Approach to Stop Hypertension dietary intervention on managing Gestational Diabetes Mellitus among pregnant women who used metformin: A randomized controlled clinical trial. Clin Nutr. 2022 Feb;41(2):384-395. doi: 10.1016/j.clnu.2021.11.039. Epub 2021 Dec 3.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年8月20日
初级完成 (预期的)
2019年8月20日
研究完成 (预期的)
2019年10月20日
研究注册日期
首次提交
2017年7月31日
首先提交符合 QC 标准的
2017年8月6日
首次发布 (实际的)
2017年8月9日
研究记录更新
最后更新发布 (实际的)
2018年11月26日
上次提交的符合 QC 标准的更新
2018年11月21日
最后验证
2018年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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