Carbohydrate Counting and DASH Intervention and Pregnancy Outcomes Among Women With Gestational Diabetes

Gestational Diabetes Mellitus With Baby Delivered Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03244579
• Other study ID #: 2
• Status: Recruiting
• Phase: N/A
• Start date: August 20, 2017
• Est. completion date: October 20, 2019

Study information

• Verified date: November 2018
• Source: University of Jordan
• Contact: Sabika S Allehdan, Msc
• Phone: +962799232789
• Email: sabika_1986[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: October 20, 2019
• Est. primary completion date: August 20, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 40 Years

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus With Baby Delivered

Intervention

Behavioral:
• Dietary Intervention
Adjusting the quantity and quality of food intake to improve glycemic control, maternal and newborn health outcomes of women with gestational diabetes.

Locations

Country	Name	City	State
Jordan	Sabika Allehdan	Amman

Sponsors (1)

Lead Sponsor	Collaborator
University of Jordan

Country where clinical trial is conducted

Jordan, 

References & Publications (6)

Kleinwechter H, Schäfer-Graf U, Bührer 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. — View Citation

Koivusalo SB, Rönö K, Klemetti MM, Roine RP, Lindström J, Erkkola M, Kaaja RJ, Pöyhönen-Alho M, Tiitinen A, Huvinen E, Andersson S, Laivuori H, Valkama A, Meinilä 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. — View Citation

Kulkarni DK. Carbohydrate counting: A practical meal-planning option for people with diabetes. Clinical Diabetes 23:120-22, 2005.

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. — View Citation

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. — View Citation

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting blood glucose	Fasting blood glucose in mg/dL at 24 -28 weeks of gestation (baseline) and at 36-37) weeks of gestation(endline) of intervention.	one year
Secondary	Hemoglobin A1c level	Hemoglobin A1c% at both baseline and endline of intervention	one year
Secondary	Fasting insulin level	Fasting insulin level in µIU/mL at both baseline and endline of intervention.	one year
Secondary	Fructosamine level	fructosamine in µmol/L at both baseline and endline of intervention.	one year
Secondary	Total maternal weight gain	Total maternal weight gain during pregnancy in kilograms	one year
Secondary	Weekly weight gain	weight in kilogram will be measured weekly for all participants	one year
Secondary	Insulin Therapy	Number of participants who need insulin therapy to normalize blood sugar.	one year
Secondary	Emergency caesarean section	Number of participants who need for emergency caesarean section versus vaginal delivery.	one year
Secondary	Pregnancy-induced hypertension	Number of participants with existence of hypertension (defined as a blood pressure of at least 140/90 mmHg on two occasions).	one year
Secondary	Newborn weight	The newborn weight in grams	one year
Secondary	Newborn Length	The new born length in centimeters.	one year
Secondary	Newborn head circumference	The newborn head circumference in centimeters.	one year
Secondary	Hypoglycemic	Number of newborn babies who will suffer from hypoglycemia	one year
Secondary	Shoulder dystocia	Number of newborn babies with shoulder dystocia.	one year