Gestational Diabetes MellitusMyLGINCT03801824
Effect of Low Glycemic Index on Gestational Diabetes Mellitus
A study testing Standard Nutrition Therapy and Low Glycemic Index in people with Gestational Diabetes Mellitus, run by Universiti Putra Malaysia at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Gestational Diabetes Mellitus
- What is being tested?
- Standard Nutrition Therapy and Low Glycemic Index
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteMalaysia
- Study dates
- Apr 2014to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
- Pregnant women, aged 18-45 years
Show all 11Show fewer
- 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
Who cannot join
- 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
- 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
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Universiti Kebangsaan Malaysia Medical Centre
Cheras, Kuala Lumpur, 56000
About this study
Official title: 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.
Read the detailed description
- 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.
- Conditions
- Gestational Diabetes Mellitus
- Being tested
- Standard Nutrition Therapy, Low Glycemic Index
- Keywords
- Gestational Diabetes Mellitus, Glycemic index, Metabolic Response, Pregnancy Outcomes, Glycemic control
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Nutrition TherapyOther
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
Low Glycemic IndexOther
Subjects will be advised to eat low glycemic index foods
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Standard Nutrition Therapy |
| Low Glycemic Index | Experimental | Subjects in this group receive intervention on low glycemic index foods Receives: Other: Low Glycemic Index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post meal blood glucose level
Average blood glucose profiles after breakfast, lunch and dinner measured using capillary blood glucose at home
Measured: 12 weeks
Secondary outcomes (3)
Level of Triglycerides
Changes in Fasting Triglycerides
Measured: 12 weeks
Level of glycemic control
Changes in Fructosamine
Measured: 4 weeks
Maternal weight gain
Changes in total weight gain based on Institute of Medicine (IOM) recommendations
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study startApr 2014
- Primary completionJun 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- National University of Malaysia
- Responsible party
- Principal investigator, Barakatun Nisak Bt Mohd Yusof, Universiti Putra Malaysia
- Investigators
- Barakatun-Nisak Mohd Yusof, PhD, Principal investigator, Universiti Putra Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03801824
- Sponsor's protocol ID
- 5450647
- Acronym
- MyLGI
- Status last verified
- Jan 2019
- First submitted
- 4 Nov 2018
- Last updated
- 25 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23344248Moses 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.
PubMed 19279301Grant 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.
PubMed 21094553Moses 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.
PubMed 17023707Perichart-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.
PubMed 23251152
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effectiveness of a Low Glycemic Index on Glycemic Control and Pregnancy Outcomes in Women With Gestational Diabetes Mellitus: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03801824
- Acronym / sponsor ID
- MyLGI / 5450647
- Conditions
- Gestational Diabetes Mellitus
- Keywords
- Gestational Diabetes Mellitus, Glycemic index, Metabolic Response, Pregnancy Outcomes, Glycemic control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Collaborators
- National University of Malaysia
- Study start
- Apr 2014 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 14 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Nutrition Therapy | Active comparator | Other: Standard Nutrition TherapySubjects 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 |
| Low Glycemic Index | Experimental | Other: Low Glycemic IndexSubjects in this group receive intervention on low glycemic index foods |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (8 listed)
- 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
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Nutrition TherapySubjects 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 | Other | Standard Nutrition Therapy |
| Low Glycemic IndexSubjects will be advised to eat low glycemic index foods | Other | Low Glycemic Index |
Primary outcome
Post meal blood glucose level
Time frame: 12 weeks
Average blood glucose profiles after breakfast, lunch and dinner measured using capillary blood glucose at home
3 secondary outcomes
Level of Triglycerides
Time frame: 12 weeks
Level of glycemic control
Time frame: 4 weeks
Maternal weight gain
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2019.
- Background: PubMed 23344248Louie 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.
- Background: PubMed 19279301Moses 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.
- Background: PubMed 21094553Grant 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.
- Background: PubMed 17023707Moses 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.
- Background: PubMed 23251152Perichart-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barakatun-Nisak Mohd Yusof, PhD principal investigator
Universiti Putra Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Nutrition Therapy and Low Glycemic Index in people with Gestational Diabetes Mellitus, run by Universiti Putra Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post meal blood glucose level (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03801824, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2019.