Effect of Low Glycemic Index on Gestational Diabetes Mellitus (MyLGI)
23. januar 2019 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
40
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Kuala Lumpur
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Cheras, Kuala Lumpur, Malaysia, 56000
- Universiti Kebangsaan Malaysia Medical Centre
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 45 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / 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
|
|
Eksperimentel: Low Glycemic Index
Subjects in this group receive intervention on low glycemic index foods
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Subjects will be advised to eat low glycemic index foods
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Level of post-meal blood glucose
Tidsramme: 3 hour post-prandial
|
Changes in post-meal blood glucose level
|
3 hour post-prandial
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Barakatun-Nisak Mohd Yusof, PhD, Universiti Putra Malaysia
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. april 2014
Primær færdiggørelse (Faktiske)
1. juni 2016
Studieafslutning (Faktiske)
1. september 2016
Datoer for studieregistrering
Først indsendt
4. november 2018
Først indsendt, der opfyldte QC-kriterier
9. januar 2019
Først opslået (Faktiske)
14. januar 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
25. januar 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. januar 2019
Sidst verificeret
1. januar 2019
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 5450647
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