MAIN STUDY: Low Glycaemic Index (GI) Diet in the Management of GDM SUB-STUDY: The Breast Milk Sub-Study

NCT01589757 | Completed Phase 2

• 1 other identifier: UofTORE26937
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 4

Brief Summary

MAIN STUDY: Low glycaemic index (GI) diets are recommended by the Canadian Diabetes Association for treating type 1 and 2 diabetes mellitus (DM), but the role of GI in the management of gestational diabetes(GDM)is not yet clear. The main purpose of this study is to determine the effect of a low GI diet on blood sugar control in women with GDM. The effect of a low GI diet on maternal oxidative stress, pregnancy and delivery outcomes and markers of risk for diabetes after birth in both the mother and baby will also be assessed. SUB-STUDY: The main purpose of the sub-study is to determine if the breast milk (BM) of women with GDM consuming a low GI diet will have a higher antioxidant capacity than the BM of women receiving a medium-high GI diet (control/standard care). The effect of a low glycaemic index diet on maternal dietary intake of specific nutrient-antioxidants (i.e. vitamin C, E, and beta-carotene) (prenatal and postpartum) and concentration of vitamin C, E, and beta-carotene in participants' transitional and mature BM will also be assessed. The ORAC (Oxygen radical absorbance capacity) assay will be used to assess overall antioxidant capacity. The antioxidant capacity of BM in women with GDM will also be compared with that of women without GDM. Hypotheses: MAIN: The use of low-GI foods in the management of GDM reduces postprandial BG and oxidative stress; thereby reducing maternal and infant perinatal complications. SUB-STUDY: Breast milk (BM) of women with GDM consuming a low GI diet will have higher BM antioxidant than women receiving the medium to high GI diet. BM of women with GDM will have lower antioxidant capacity than that of women without GDM.

Conditions

Gestational Diabetes Mellitus

Keywords

"glycaemic index"; "glycemic index"; hyperglycaemia; hyperglycemia; pregnancy; "dietary intervention"; "education evaluation"; antioxidant; "Impaired Glucose Tolerance of Pregnancy"; "Gestational Diabetes Mellitus"; "Breast Milk"

Outcome Measures

Primary Outcomes (2)

• MAIN STUDY: Percentage of postprandial self monitored blood glucose (SMBG) values within the target range

  SMBG values are obtained 4 times daily (1 fasting and 3 postprandial) throughout the study from the randomization to delivery. The endpoint is a single value for each participant - namely the percentage of all the postprandial SMBG values within the target range recommended by the Canadian Diabetes Association (5.0 to 6.6 mmol/L)

  From randomization to delivery

• SUB-STUDY (n=75): Oxygen Radical Absorbance Capacity (ORAC) (Antioxidant Capacity) of transitional and mature breast milk.

  Breast milk samples (25 mL) will be collected 1 week and 8 weeks after birth from a complete breast milk collection. Measures will be compared between and within groups.

  1 week and 8 weeks postpartum

Secondary Outcomes (51)

• MAIN STUDY: Infant birth weight

  At delivery

• MAIN STUDY: Percentage of self-monitored fasting glucose values within the target range

  From randomization to delivery

• MAIN STUDY: Glucose variability

  From randomization to delivery

• MAIN STUDY: Insulin prescription incidence

  From randomization to delivery

• MAIN STUDY: Mean fasting glucose

  From randomization to delivery

Study Arms (2)

Standard Care

PLACEBO COMPARATOR

Standard care dietary advice to emphasize high fiber foods with a moderate to high GI

Other: Low GI diet

Low GI Diet

EXPERIMENTAL

Low GI dietary advice in addition to standard care

Other: Standard Care

Interventions

Standard Care OTHER

Standard dietary advice for women with GDM with special emphasis on use of high fiber or whole grain carbohydrate foods with a medium to high GI. What's on Your Plate? and 3-dimensional food models will be used to teach servings size and meal planning. This groups will be provided with food substitution lists (key-foods method) composed of medium to high GI foods.

Also known as: medium to high Glycaemic Index

Low GI Diet

Low GI diet OTHER

Nutrition education according to standard care similar to the control group with supplementary GI-education. GI-education will be taught using the "Stop-Light-Method". This groups will be provided with food substitution lists (key-foods method) composed of low-GI carbohydrate-containing food. The GI-education tool(s) will build on standard care education where patients are taught which food groups contain carbohydrate.

Also known as: glycemic index, glycaemic index, low glycemic carbohydrates, low glycaemic carbohydrates

Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women:
• ≥ 18 years of age
• diagnosed with gestational diabetes mellitus (GDM) or impaired glucose tolerance of pregnancy (IGTP) according to Canadian Diabetes Association (CDA) criteria
• being followed within DIP (one of 4 sites)
• willing and able to give informed consent
• willing and able to comply with the study protocol

You may not qualify if:

• Women:
• with acute or chronic illness other than GDM or IGTP or use of drug (other than insulin) which may affect carbohydrate metabolism, gastrointestinal function or carbohydrate digestion (i.e. crohn's disease, HIV/AIDS, liver disease, kidney disease etc.).
• known to have type 1 or type 2 DM prior to pregnancy
• known multi-fetal pregnancy at enrolment
• ≥ 33 weeks' gestation
• prescribed oral anti-hyperglycaemic medication
• insurmountable language barriers
• SUB-STUDY control group (women without GDM) Same as for Main study except absence of GDM

Sponsors & Collaborators

• University of Toronto: lead
• Canadian Diabetes Association: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator
• Canadian Foundation for Dietetic Research (CFDR): collaborator

Study Sites (4)

MAIN STUDY ONLY: St Joseph's Heathcare Hamilton, 50 Charlton Avenue East

Hamilton, Ontario, L8N 4A6, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Mt Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, Room H145, 2075 Bayview Avenue, Canada

Location

Related Publications (7)

• Ceriello A. Acute hyperglycaemia and oxidative stress generation. Diabet Med. 1997 Aug;14 Suppl 3:S45-9. doi: 10.1002/(sici)1096-9136(199708)14:3+3.3.co;2-i.

  PMID: 9272613 BACKGROUND

• Ceriello A. The emerging role of post-prandial hyperglycaemic spikes in the pathogenesis of diabetic complications. Diabet Med. 1998 Mar;15(3):188-93. doi: 10.1002/(SICI)1096-9136(199803)15:33.0.CO;2-V. No abstract available.

  PMID: 9545118 BACKGROUND

• Huang D, Ou B, Prior RL. The chemistry behind antioxidant capacity assays. J Agric Food Chem. 2005 Mar 23;53(6):1841-56. doi: 10.1021/jf030723c.

  PMID: 15769103 BACKGROUND

• Saenz AT, Elisia I, Innis SM, Friel JK, and Kitts DD. Use of ORAC to assess antioxidant capacity of human milk. Journal of Food Composition and Analysis 22:694-698, 2009

  BACKGROUND

• Elisia I, Kitts DD. Quantification of hexanal as an index of lipid oxidation in human milk and association with antioxidant components. J Clin Biochem Nutr. 2011 Nov;49(3):147-52. doi: 10.3164/jcbn.10-142. Epub 2011 Sep 3.

  PMID: 22128211 BACKGROUND

• Wolever, TMS. The Glycaemic Index: A Physiological Classification of Dietary Carbohydrate. Ontario, Canada: CABI, 2006.

  BACKGROUND

• Grant SM, Wolever TMS. Perceived barriers to application of glycaemic index: valid concerns or lost in translation? Nutrients. 2011 Mar;3(3):330-340. doi: 10.3390/nu3030330. Epub 2011 Feb 28.

  PMID: 22254100 BACKGROUND

MeSH Terms

Conditions

Diabetes, Gestational; Hyperglycemia

Interventions

Standard of Care; Glycemic Index

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Nutritive Value; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Food Quality; Food Technology; Food Industry; Industry; Technology, Industry, and Agriculture; Public Health; Environment and Public Health

Study Officials

• Thomas MS Wolever, MD, PhD

  University of Toronto/ St Michael's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 19, 2012
• First Posted: May 2, 2012
• Study Start: October 1, 2011
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: May 20, 2016

Record last verified: 2016-05

Locations

CA (4)