Effect of Low Glycemic Index on Gestational Diabetes Mellitus (MyLGI)
23. januar 2019 oppdatert av: Barakatun Nisak Bt Mohd Yusof, Universiti Putra Malaysia
Investigating the Effectiveness of a Low Glycemic Index on Glycemic Control and Pregnancy Outcomes in Women With Gestational Diabetes Mellitus: A Randomised Controlled Trial
The purpose of this study is to determine whether glycemic index is effective in the treatment of maternal glycemia and pregnancy outcomes in women with Gestational Diabetes Mellitus.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
1. This research is divided into 2, that are study I and study II
Study I, is to determine the long-term effects of intervention (low GI and SNT) on maternal glycemia, pregnancy outcomes and postprandial metabolic markers in women with GDM
- A total of 110 women with confirmed diagnosis of GDM will be recruited
- They will be randomized either to receive low GI (n=55) or Standard Nutrition Therapy (SNT; n=55)
- The intervention will be started as soon as the women being diagnosed with GDM and they will be followed-up every month until delivery and up to the 3-month postpartum.
- The primary outcome measures include glycemic control parameters as assessed by fasting and postprandial glycemia, fructosamine, HbA1c, insulin level and requirement for insulin treatment.
- Secondary outcomes include lipid profile, weight gain, measures of postprandial metabolic response (free fatty acid and triglyceride), pregnancy outcomes, and overall improvement in postpartum metabolic parameters.
Study II, a sub-Mixed-meal Tolerant Test (MTT) study will be conducted to determine postprandial glycemic and metabolic responses before and after 4-weeks of intensive intervention
- During the 4-weeks of intensive intervention, the subjects will receive individualise counseling and daily food supply regarding the allocated study group.
- A minimum of 19 subjects from a pool of 110 subjects who is participated in the intervention study will be recruited.
- The MTT procedure is similar to the oral glucose tolerant test (OGTT) but the subject will be asked to consume the real mixed meals representing low and high GI foods rather than oral glucose solution.
- Subject will be asked to consume the test meal (either low or high GI foods) and the blood will be sampled before and after consuming the test meal in two different occasions with 1-week wash-out period.
- After one month of intensive intervention, 19 subjects from each arm will undergo the final HGI meal tolerant test (MTT3) and the same procedure of MTT 1 and 2
- Approximately 32μl of capillary blood by finger-prick will be obtained 7 times per MTT session, which is every 30 minutes thereafter to complete 3-h postprandial meal for each set of meal tests.
Studietype
Intervensjonell
Registrering (Faktiske)
40
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Kuala Lumpur
-
Cheras, Kuala Lumpur, Malaysia, 56000
- Universiti Kebangsaan Malaysia Medical Centre
-
-
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
18 år til 45 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
Study I
Inclusion Criteria:
- Pregnant women, aged 18-45 years
- Women diagnosed with Gestational Diabetes Mellitus (GDM) as early as 13 up to 28 weeks of gestation
- Pre-pregnancy BMI >23kg/m2 (using BMI cut-off point) for underweight and overweight of Asian as defined by World Health Organization (WHO, 2000)
- Treated with diet controlled or on insulin therapy
- Willing and able to comply with the study protocol
Exclusion Criteria:
- Any gastrointestinal disease that interferes with bowel function and nutritional intake (i.e., diabetes-related constipation or diarrhea secondary to neuropathy, diarrhea due to chronic inflammatory bowel disease, gastroparesis, gastrectomy, galactosemia, hyperemesis
- Any medical problem that requires steroid (i.e., arthritis, asthma, autoimmune diseases and skin conditions such as eczema
- Incapability to comply with study protocol or investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
Study II
Inclusion Criteria:
- Pregnant women, aged 18-45 years
- Only women diagnosed with Gestational Diabetes Mellitus (GDM) between 16 and 28 weeks of gestation
- Pre-pregnancy BMI >23kg/m2 (using BMI cut-off point) for underweight and overweight of Asian as defined by WHO (2000)
- Treated with diet-controlled alone
- Hemoglobin ≥10mmol/l (WHO, 2011)
- Willing and able to comply with the protocol
Exclusion Criteria:
- Any gastrointestinal disease that interferes with bowel function and nutritional intake (i.e., diabetes-related constipation or diarrhea secondary to neuropathy, diarrhea due to chronic inflammatory bowel disease, gastroparesis, gastrectomy, galactosemia, hyperemesis)
- Currently on insulin therapy
- With known food allergy/ on a particular dietary requirement
- Incapability to comply with study protocol or investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Standard Nutrition Therapy
Subjects in this group receive a standard nutrition therapy based on local guidelines that is usually high in fibre with moderate to high glycemic index food
|
Subjects will be advised on standard diet appropriate for the management of Gestational Diabetes Mellitus (GDM) designed to be high in fiber and have moderate to high dietary glycemic index
|
|
Eksperimentell: Low Glycemic Index
Subjects in this group receive intervention on low glycemic index foods
|
Subjects will be advised to eat low glycemic index foods
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Post meal blood glucose level
Tidsramme: 12 weeks
|
Average blood glucose profiles after breakfast, lunch and dinner measured using capillary blood glucose at home
|
12 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Level of Triglycerides
Tidsramme: 12 weeks
|
Changes in Fasting Triglycerides
|
12 weeks
|
|
Level of glycemic control
Tidsramme: 4 weeks
|
Changes in Fructosamine
|
4 weeks
|
|
Maternal weight gain
Tidsramme: 12 weeks
|
Changes in total weight gain based on Institute of Medicine (IOM) recommendations
|
12 weeks
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Level of post-meal blood glucose
Tidsramme: 3 hour post-prandial
|
Changes in post-meal blood glucose level
|
3 hour post-prandial
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Barakatun-Nisak Mohd Yusof, PhD, Universiti Putra Malaysia
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
- Louie JC, Markovic TP, Ross GP, Foote D, Brand-Miller JC. Timing of peak blood glucose after breakfast meals of different glycemic index in women with gestational diabetes. Nutrients. 2012 Dec 21;5(1):1-9. doi: 10.3390/nu5010001.
- Moses RG, Barker M, Winter M, Petocz P, Brand-Miller JC. Can a low-glycemic index diet reduce the need for insulin in gestational diabetes mellitus? A randomized trial. Diabetes Care. 2009 Jun;32(6):996-1000. doi: 10.2337/dc09-0007. Epub 2009 Mar 11.
- Grant SM, Wolever TM, O'Connor DL, Nisenbaum R, Josse RG. Effect of a low glycaemic index diet on blood glucose in women with gestational hyperglycaemia. Diabetes Res Clin Pract. 2011 Jan;91(1):15-22. doi: 10.1016/j.diabres.2010.09.002. Epub 2010 Nov 20.
- Moses RG, Luebcke M, Davis WS, Coleman KJ, Tapsell LC, Petocz P, Brand-Miller JC. Effect of a low-glycemic-index diet during pregnancy on obstetric outcomes. Am J Clin Nutr. 2006 Oct;84(4):807-12. doi: 10.1093/ajcn/84.4.807.
- Perichart-Perera O, Balas-Nakash M, Rodriguez-Cano A, Legorreta-Legorreta J, Parra-Covarrubias A, Vadillo-Ortega F. Low Glycemic Index Carbohydrates versus All Types of Carbohydrates for Treating Diabetes in Pregnancy: A Randomized Clinical Trial to Evaluate the Effect of Glycemic Control. Int J Endocrinol. 2012;2012:296017. doi: 10.1155/2012/296017. Epub 2012 Nov 29.
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)
1. april 2014
Primær fullføring (Faktiske)
1. juni 2016
Studiet fullført (Faktiske)
1. september 2016
Datoer for studieregistrering
Først innsendt
4. november 2018
Først innsendt som oppfylte QC-kriteriene
9. januar 2019
Først lagt ut (Faktiske)
14. januar 2019
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
25. januar 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
23. januar 2019
Sist bekreftet
1. januar 2019
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 5450647
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .