Effect of Low Glycemic Index on Gestational Diabetes Mellitus

NCT03801824 | Completed DMC

• 1 other identifier: 5450647
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gestational Diabetes Mellitus

Keywords

Gestational Diabetes Mellitus; Glycemic index; Metabolic Response; Pregnancy Outcomes; Glycemic control

Outcome Measures

Primary Outcomes (1)

• Post meal blood glucose level

  Average blood glucose profiles after breakfast, lunch and dinner measured using capillary blood glucose at home

  12 weeks

Secondary Outcomes (3)

• Level of Triglycerides

  12 weeks

• Level of glycemic control

  4 weeks

• Maternal weight gain

  12 weeks

Other Outcomes (1)

• Level of post-meal blood glucose

  3 hour post-prandial

Study Arms (2)

Standard Nutrition Therapy

ACTIVE COMPARATOR

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

Other: Standard Nutrition Therapy

Low Glycemic Index

EXPERIMENTAL

Subjects in this group receive intervention on low glycemic index foods

Other: Low Glycemic Index

Interventions

Standard Nutrition Therapy OTHER

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

Standard Nutrition Therapy

Low Glycemic Index OTHER

Subjects will be advised to eat low glycemic index foods

Low Glycemic Index

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Universiti Putra Malaysia: lead
• National University of Malaysia: collaborator

Study Sites (1)

Universiti Kebangsaan Malaysia Medical Centre

Cheras, Kuala Lumpur, 56000, Malaysia

Location

Related Publications (5)

• 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.

  PMID: 23344248 BACKGROUND

• 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.

  PMID: 19279301 BACKGROUND

• 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.

  PMID: 21094553 BACKGROUND

• 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.

  PMID: 17023707 BACKGROUND

• 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.

  PMID: 23251152 BACKGROUND

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Barakatun-Nisak Mohd Yusof, PhD

  Universiti Putra Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 4, 2018
• First Posted: January 14, 2019
• Study Start: April 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: September 1, 2016
• Last Updated: January 25, 2019

Record last verified: 2019-01

Locations

MY (1)