- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03244579
Carbohydrate Counting and DASH Intervention and Pregnancy Outcomes Among Women With Gestational Diabetes
21. november 2018 oppdatert av: 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.
Studieoversikt
Status
Ukjent
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Forventet)
180
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Sabika S Allehdan, Msc
- Telefonnummer: +962799232789
- E-post: sabika_1986@yahoo.com
Studer Kontakt Backup
- Navn: Reema F Tayyem, PhD
- Telefonnummer: +962797902535
- E-post: r_tayyem@yahoo.com
Studiesteder
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-
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Amman, Jordan, 009626
- Rekruttering
- Sabika Allehdan
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Ta kontakt med:
- Sabika Allehdan, MSc
- Telefonnummer: 799232789
- E-post: sabika_1986@Yahoo.com
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
25 år til 40 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
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).
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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.
Andre navn:
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Eksperimentell: 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.
Andre navn:
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Ingen inngripen: General Dietary guidlines
the general dietary advice and diet that will be prescribed by hospital for participants
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Fasting blood glucose
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Hemoglobin A1c level
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: one year
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The newborn weight in grams
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one year
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Newborn Length
Tidsramme: 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
Tidsramme: one year
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The newborn head circumference in centimeters.
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one year
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Hypoglycemic
Tidsramme: 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
Tidsramme: one year
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Number of newborn babies with shoulder dystocia.
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one year
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Reema F Tayyem, PhD, University of Jordan
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
20. august 2017
Primær fullføring (Forventet)
20. august 2019
Studiet fullført (Forventet)
20. oktober 2019
Datoer for studieregistrering
Først innsendt
31. juli 2017
Først innsendt som oppfylte QC-kriteriene
6. august 2017
Først lagt ut (Faktiske)
9. august 2017
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
26. november 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
21. november 2018
Sist bekreftet
1. november 2018
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2
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