Clinical trial NCT03244579: Carbohydrate Counting and DASH Intervention and Pregnancy Outcomes Among Women With Gestational Diabetes
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gestational Diabetes Mellitus With Baby Delivered
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2017-08-09
Enrollment: 180
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Fasting blood glucose
timeFrame: one year
Secondary outcomes:
measure: Hemoglobin A1c level
timeFrame: one year
measure: Fasting insulin level
timeFrame: one year
measure: Fructosamine level
timeFrame: one year
measure: Total maternal weight gain
timeFrame: one year
measure: Weekly weight gain
timeFrame: one year
measure: Insulin Therapy
timeFrame: one year
measure: Emergency caesarean section
timeFrame: one year
measure: Pregnancy-induced hypertension
timeFrame: one year
measure: Newborn weight
timeFrame: one year
measure: Newborn Length
timeFrame: one year
measure: Newborn head circumference
timeFrame: one year
measure: Hypoglycemic
timeFrame: one year
measure: Shoulder dystocia
timeFrame: one year
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Sabika Allehdan
Study officials:
affiliation: University of Jordan
name: Reema F Tayyem, PhD
role: STUDY_DIRECTOR
References:
citation: Kulkarni DK. Carbohydrate counting: A practical meal-planning option for people with diabetes. Clinical Diabetes 23:120-22, 2005.
citation: 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.
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.
citation: 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.
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.
citation: 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.
citation: 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.