Type 2 DiabetesNCT04190199
Exploring Nutritype Signature of Type 2 Diabetes Risks in Women Post-Gestational Diabetes Mellitus
An observational study of Type 2 Diabetes and Gestational Diabetes, run by Universiti Putra Malaysia at 1 site in Malaysia.
Trial summary
Women post-gestational diabetes mellitus (GDM) have more than 7-fold increased risk of having future type 2 diabetes mellitus (T2DM). While a healthful dietary pattern reduces the risk of diabetes in post-GDM, no data support a dietary pattern tailored to the Malaysian diet. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Gestational Diabetes
- What is being tested?
- Observational
- How many people
- 270 participants
- Where
- 1 siteMalaysia
- Study dates
- May 2020to May 2021
- Phase
- Observational
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women with previous GDM will be screened for inclusion and exclusion criteria. Those eligible will be asked to come to the clinic for the further ascertainment of the current status of T2DM by undergoing oral glucose tolerance test (OGTT) based on the criteria set by CPG DM (2015). Based on this diagnostic criteria, they will be divided into 3 groups: either T2DM, pre-diabetes (IFG/IGT), or non-T2DM.
Who may be able to join
- Malaysian women at childbearing age of 18-50 years old
- Have a history of GDM
- Women with known case of impaired fasting glucose (IFG) or impaired glucose tolerance (IGT) with or without medications
Who cannot join
- Pregnant women
- Those with prior history of type 1 or type 2 diabetes
- Recent hospitalization (within 6 weeks)
- Presence of reported or previously diagnosed medical conditions
- Receiving drugs (such as steroids and weight-reducing agents)
- Have a significant weight loss of 10% from original body weight within 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Women post-gestational diabetes mellitus (GDM) have more than 7-fold increased risk of having future type 2 diabetes mellitus (T2DM). While a healthful dietary pattern reduces the risk of diabetes in post-GDM, no data support a dietary pattern tailored to the Malaysian diet. To address this issue, the investigators propose to determine the effects of dietary patterns and plasma metabolites in predicting the risk of T2DM known as the Nutritype model. The aim of this study is to identify Nutritype signatures of T2DM risk in women post-GDM using metabolomics approach.
Read the detailed description
Women with a history of gestational diabetes mellitus (GDM) or post-GDM are at high risk of developing type 2 diabetes (T2DM). This is important in the present context because T2DM has reached epidemic proportions. In Malaysia, the prevalence of T2DM has increased by almost 80% in just over a 10 year period. Current recommendation supports early screening at 6 weeks postpartum via oral glucose tolerance testing (OGTT) after GDM. However, the screening of women after GDM remains suboptimal, with a very low compliance rate up to almost 20%. Also, none of the recommendations highlights the need of having nutrition screening assessments despite the fact that nutritional stimuli are highly relevant to expedite disease progression in women post-GDM.
As such, the metabolomics technique can be used as a tool to measure the full profile of small-molecule metabolites in bio-fluids. This technique has been expanded beyond biological disciplines towards nutrition research leading to the emerging concept of Nutritype. Nutritype refers to the expression of overall dietary intake in metabolites; work that capable to classify individuals into a certain dietary pattern based on the metabolomics profiles. While the role of metabolomics is significance, no exploration of the Nutritype signatures has been established.
Potential significant determinants for the progression from GDM to T2DM include genetics, factors during the index pregnancy, exogenous modifiable risk factors and factors specific to intermediate biological mechanisms with no data on metabolites profile. Although the metabolomic signatures predicting GDM transition to T2DM in women post-GDM have been identified, its metabolites related to a protective dietary pattern is unknown.
This concept is timely needed as the objective assessment of dietary intake is a huge challenge that lacks biological validation. Although several biomarkers of foods exist, identification of metabolites signature that reflects overall dietary patterns is scarce. While a healthful dietary pattern such as the alternate Healthy Eating Index (aHEI) reduces the risk of T2DM among women post-GDM, none of the patterns tailored to Malaysian diet. Direct extrapolation of these findings to the overall Malaysian diet is unknown.
Therefore, the study aims to discover and identify the Nutritype signatures which combine information on dietary pattern biomarkers and metabolites profiles of T2DM risk in women post-GDM using metabolomics approach. The data will then be used to identify a predictive model of Nutritype signatures to develop protective dietary pattern works according to individuals' metabolite in preventing T2DM among women post-GDM. The findings aid in establishing an early measure of T2DM prevention in women post-GDM based on the metabolite profile that reflects the overall diet. This new exciting work leads to the goal of achieving precision diabetes-nutrition prevention using a multi-pronged strategy.
This is a cross-sectional comparative study involving women post-GDM. Women with a history of GDM will have their nutritional status, metabolite profile, dietary pattern and lifestyle practices assessed. They will undergo Oral Glucose Tolerance Test (OGTT) to determine T2DM diagnosis, based on Clinical Practice Guidelines Malaysia. Based on their OGTT results, they will be divided into 3 groups: T2DM, prediabetes (impaired fasting glucose [IFG] or impaired glucose tolerance [IGT]), or non-T2DM.
- Conditions
- Type 2 Diabetes, Gestational Diabetes
- Being tested
- Observational
- Keywords
- Metabolomic, Nutritype, Dietary Pattern
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Cross-sectional only
| Study group | Role | What they receive |
|---|---|---|
| Type 2 diabetes mellitus (T2DM) | Subjects in this group are diagnosed with type 2 diabetes mellitus. They receive no intervention. Their nutritional status, metabolite profile, dietary pattern, and lifestyle practices will be assessed. Receives: Other: Observational | |
| Pre-diabetes (IFG or IGT) | Subjects in this group are diagnosed with pre-diabetes (impaired fasting glucose [IFG] or impaired glucose tolerance [IGT]). They receive no intervention. Their nutritional status, metabolite profile, dietary pattern, and lifestyle practices will be assessed. Receives: Other: Observational | |
| Non-type 2 diabetes mellitus (healthy) | Subjects in this group are not diagnosed with type 2 diabetes mellitus or pre-diabetes (healthy). They receive no intervention. Their nutritional status, metabolite profile, dietary pattern, and lifestyle practices will be assessed. Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutritype signature of T2DM risks in women post-GDM
To identify the nutritype signatures of T2DM risks in women post-GDM using proton nuclear magnetic resonance (1H NMR) based metabolomics approach.
Measured: Through study completion, an average of 1 year
Secondary outcomes (10)
Prevalence of glucose intolerance
To determine prevalence of glucose intolerance (T2DM and pre-diabetes) among women post-GDM
Measured: Through study completion, an average of 1 year
Socio-demographic background
Difference in socio-demographic background between T2DM, pre-diabetes and non-T2DM groups.
Measured: Through study completion, an average of 1 year
Obstetric history
Difference in obstetric history between T2DM, pre-diabetes and non-T2DM groups.
Measured: Through study completion, an average of 1 year
Nutritional status
Difference in nutritional status between T2DM, pre-diabetes and non-T2DM groups.
Measured: Through study completion, an average of 1 year
Metabolite profile
Difference in metabolite profile between T2DM, pre-diabetes and non-T2DM groups.
Metabolite profile will be analyzed based plasma blood and urine samples, using 1H NMR metabolomics approach.
Measured: Through study completion, an average of 1 year
Dietary pattern
Difference in dietary pattern between T2DM, pre-diabetes and non-T2DM groups. Dietary pattern will be assessed using Food Frequency Questionnaire.
Measured: Through study completion, an average of 1 year
Sleeping pattern
Difference in sleeping pattern between T2DM, pre-diabetes and non-T2DM groups. Sleeping pattern will be assessed using a questionnaire.
Measured: Through study completion, an average of 1 year
Perceived Stress Scale score
Difference in Perceived Stress Scale score between T2DM, pre-diabetes and non-T2DM groups.
PSS scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 \& 4 = 0) to the four positively stated items (items 4, 5, 7, \& 8) and then summing across all scale items. Minimum score is 10, whereas maximum score is 40.
Measured: Through study completion, an average of 1 year
Physical activity level
Difference in physical activity level between T2DM, pre-diabetes and non-T2DM groups. Physical activity level will be assessed by International Physical Activity Questionnaire (IPAQ).
Measured: Through study completion, an average of 1 year
Smoking habit and exposure
Difference in smoking habit and exposure between T2DM, pre-diabetes and non-T2DM groups. Questions on smoking habit and exposure are based on the Global Adult Tobacco Survey.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study startMay 2020 (estimated)
- Primary completionMay 2021 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Malaysia, Universiti Teknologi Mara
- Responsible party
- Principal investigator, Barakatun Nisak Bt Mohd Yusof, Universiti Putra Malaysia
- Investigators
- Barakatun Nisak Mohd. Yusof, PhD, Principal investigator, Universiti Putra MalaysiaFarah Yasmin Hasbullah, MSc, Principal investigator, Universiti Putra MalaysiaGeeta Appannah, PhD, Principal investigator, Universiti Putra MalaysiaRohana Abdul Ghani, PhD, Principal investigator, Universiti Teknologi Mara (UiTM)Zulfitri 'Azuan Mat Daud, PhD, Principal investigator, Universiti Putra MalaysiaWinnie Chee, PhD, Principal investigator, International Medical University (IMU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04190199
- Sponsor's protocol ID
- 5540099
- Status last verified
- Dec 2019
- First submitted
- 1 Dec 2019
- Last updated
- 9 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Allalou A, Nalla A, Prentice KJ, Liu Y, Zhang M, Dai FF, Ning X, Osborne LR, Cox BJ, Gunderson EP, Wheeler MB. A Predictive Metabolic Signature for the Transition From Gestational Diabetes Mellitus to Type 2 Diabetes. Diabetes. 2016 Sep;65(9):2529-39. doi: 10.2337/db15-1720. Epub 2016 Jun 23.
PubMed 27338739Bhupathiraju SN, Hu FB. One (small) step towards precision nutrition by use of metabolomics. Lancet Diabetes Endocrinol. 2017 Mar;5(3):154-155. doi: 10.1016/S2213-8587(17)30007-4. Epub 2017 Jan 13. No abstract available.
PubMed 28089710Institute for Public Health [IPH]. 2015. Vol. II: Non-communicable diseases, risk factors and other health problems. National Health and Morbidity Survey (NHMS 2015). Kuala Lumpur, Malaysia: IPH, Ministry of Health.
Malaysian Endocrine & Metabolic Society [MEMS] and Ministry of Health [MOH] Malaysia. 2015. Management of type 2 diabetes mellitus (5th Edition). Kuala Lumpur, Malaysia: MEMS & MOH.
Nielsen KK, Kapur A, Damm P, de Courten M, Bygbjerg IC. From screening to postpartum follow-up - the determinants and barriers for gestational diabetes mellitus (GDM) services, a systematic review. BMC Pregnancy Childbirth. 2014 Jan 22;14:41. doi: 10.1186/1471-2393-14-41.
PubMed 24450389O'Gorman A, Brennan L. The role of metabolomics in determination of new dietary biomarkers. Proc Nutr Soc. 2017 Aug;76(3):295-302. doi: 10.1017/S0029665116002974. Epub 2017 Jan 16.
PubMed 28091346Tee ES, Yap RWK. Type 2 diabetes mellitus in Malaysia: current trends and risk factors. Eur J Clin Nutr. 2017 Jul;71(7):844-849. doi: 10.1038/ejcn.2017.44. Epub 2017 May 17.
PubMed 28513624Tobias DK, Hu FB, Chavarro J, Rosner B, Mozaffarian D, Zhang C. Healthful dietary patterns and type 2 diabetes mellitus risk among women with a history of gestational diabetes mellitus. Arch Intern Med. 2012 Nov 12;172(20):1566-72. doi: 10.1001/archinternmed.2012.3747.
PubMed 22987062Zhang C, Hu FB, Olsen SF, Vaag A, Gore-Langton R, Chavarro JE, Bao W, Yeung E, Bowers K, Grunnet LG, Sherman S, Kiely M, Strom M, Hansen S, Liu A, Mills J, Fan R; DWH study team. Rationale, design, and method of the Diabetes & Women's Health study--a study of long-term health implications of glucose intolerance in pregnancy and their determinants. Acta Obstet Gynecol Scand. 2014 Nov;93(11):1123-30. doi: 10.1111/aogs.12425. Epub 2014 Jun 9.
PubMed 24828694Kim C, Newton KM, Knopp RH. Gestational diabetes and the incidence of type 2 diabetes: a systematic review. Diabetes Care. 2002 Oct;25(10):1862-8. doi: 10.2337/diacare.25.10.1862.
PubMed 12351492
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Nutritype Signature of Type 2 Diabetes Risks in Women Post-Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04190199
- Acronym / sponsor ID
- 5540099
- Conditions
- Type 2 Diabetes, Gestational Diabetes
- Keywords
- Metabolomic, Nutritype, Dietary Pattern
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Collaborators
- Ministry of Health, Malaysia, Universiti Teknologi Mara
- Study start
- May 2020 (estimated)
- Primary completion
- May 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 9 Dec 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.
Women post-gestational diabetes mellitus (GDM) have more than 7-fold increased risk of having future type 2 diabetes mellitus (T2DM). While a healthful dietary pattern reduces the risk of diabetes in post-GDM, no data support a dietary pattern tailored to the Malaysian diet. To address this issue, the investigators propose to determine the effects of dietary patterns and plasma metabolites in predicting the risk of T2DM known as the Nutritype model. The aim of this study is to identify Nutritype signatures of T2DM risk in women post-GDM using metabolomics approach.
Detailed description
Women with a history of gestational diabetes mellitus (GDM) or post-GDM are at high risk of developing type 2 diabetes (T2DM). This is important in the present context because T2DM has reached epidemic proportions. In Malaysia, the prevalence of T2DM has increased by almost 80% in just over a 10 year period. Current recommendation supports early screening at 6 weeks postpartum via oral glucose tolerance testing (OGTT) after GDM. However, the screening of women after GDM remains suboptimal, with a very low compliance rate up to almost 20%. Also, none of the recommendations highlights the need of having nutrition screening assessments despite the fact that nutritional stimuli are highly relevant to expedite disease progression in women post-GDM.
As such, the metabolomics technique can be used as a tool to measure the full profile of small-molecule metabolites in bio-fluids. This technique has been expanded beyond biological disciplines towards nutrition research leading to the emerging concept of Nutritype. Nutritype refers to the expression of overall dietary intake in metabolites; work that capable to classify individuals into a certain dietary pattern based on the metabolomics profiles. While the role of metabolomics is significance, no exploration of the Nutritype signatures has been established.
Potential significant determinants for the progression from GDM to T2DM include genetics, factors during the index pregnancy, exogenous modifiable risk factors and factors specific to intermediate biological mechanisms with no data on metabolites profile. Although the metabolomic signatures predicting GDM transition to T2DM in women post-GDM have been identified, its metabolites related to a protective dietary pattern is unknown.
This concept is timely needed as the objective assessment of dietary intake is a huge challenge that lacks biological validation. Although several biomarkers of foods exist, identification of metabolites signature that reflects overall dietary patterns is scarce. While a healthful dietary pattern such as the alternate Healthy Eating Index (aHEI) reduces the risk of T2DM among women post-GDM, none of the patterns tailored to Malaysian diet. Direct extrapolation of these findings to the overall Malaysian diet is unknown.
Therefore, the study aims to discover and identify the Nutritype signatures which combine information on dietary pattern biomarkers and metabolites profiles of T2DM risk in women post-GDM using metabolomics approach. The data will then be used to identify a predictive model of Nutritype signatures to develop protective dietary pattern works according to individuals' metabolite in preventing T2DM among women post-GDM. The findings aid in establishing an early measure of T2DM prevention in women post-GDM based on the metabolite profile that reflects the overall diet. This new exciting work leads to the goal of achieving precision diabetes-nutrition prevention using a multi-pronged strategy.
This is a cross-sectional comparative study involving women post-GDM. Women with a history of GDM will have their nutritional status, metabolite profile, dietary pattern and lifestyle practices assessed. They will undergo Oral Glucose Tolerance Test (OGTT) to determine T2DM diagnosis, based on Clinical Practice Guidelines Malaysia. Based on their OGTT results, they will be divided into 3 groups: T2DM, prediabetes (impaired fasting glucose [IFG] or impaired glucose tolerance [IGT]), or non-T2DM.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Type 2 diabetes mellitus (T2DM) | – | Other: ObservationalSubjects in this group are diagnosed with type 2 diabetes mellitus. They receive no intervention. Their nutritional status, metabolite profile, dietary pattern, and lifestyle practices will be assessed. |
| Pre-diabetes (IFG or IGT) | – | Other: ObservationalSubjects in this group are diagnosed with pre-diabetes (impaired fasting glucose [IFG] or impaired glucose tolerance [IGT]). They receive no intervention. Their nutritional status, metabolite profile, dietary pattern, and lifestyle practices will be assessed. |
| Non-type 2 diabetes mellitus (healthy) | – | Other: ObservationalSubjects in this group are not diagnosed with type 2 diabetes mellitus or pre-diabetes (healthy). They receive no intervention. Their nutritional status, metabolite profile, dietary pattern, and lifestyle practices will be assessed. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women with previous GDM will be screened for inclusion and exclusion criteria. Those eligible will be asked to come to the clinic for the further ascertainment of the current status of T2DM by undergoing oral glucose tolerance test (OGTT) based on the criteria set by CPG DM (2015). Based on this diagnostic criteria, they will be divided into 3 groups: either T2DM, pre-diabetes (IFG/IGT), or non-T2DM.
Key inclusion criteria (3 listed)
- Malaysian women at childbearing age of 18-50 years old
- Have a history of GDM
- Women with known case of impaired fasting glucose (IFG) or impaired glucose tolerance (IGT) with or without medications
Key exclusion criteria (6 listed)
- Pregnant women
- Those with prior history of type 1 or type 2 diabetes
- Recent hospitalization (within 6 weeks)
- Presence of reported or previously diagnosed medical conditions
- Receiving drugs (such as steroids and weight-reducing agents)
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 |
|---|---|---|
| ObservationalCross-sectional only | Other | Non-type 2 diabetes mellitus (healthy), Pre-diabetes (IFG or IGT), Type 2 diabetes mellitus (T2DM) |
Primary outcome
Nutritype signature of T2DM risks in women post-GDM
Time frame: Through study completion, an average of 1 year
To identify the nutritype signatures of T2DM risks in women post-GDM using proton nuclear magnetic resonance (1H NMR) based metabolomics approach.
10 secondary outcomes
Prevalence of glucose intolerance
Time frame: Through study completion, an average of 1 year
Socio-demographic background
Time frame: Through study completion, an average of 1 year
Obstetric history
Time frame: Through study completion, an average of 1 year
Nutritional status
Time frame: Through study completion, an average of 1 year
Metabolite profile
Time frame: Through study completion, an average of 1 year
Dietary pattern
Time frame: Through study completion, an average of 1 year
Sleeping pattern
Time frame: Through study completion, an average of 1 year
Perceived Stress Scale score
Time frame: Through study completion, an average of 1 year
Physical activity level
Time frame: Through study completion, an average of 1 year
Smoking habit and exposure
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2019.
- Background: PubMed 27338739Allalou A, Nalla A, Prentice KJ, Liu Y, Zhang M, Dai FF, Ning X, Osborne LR, Cox BJ, Gunderson EP, Wheeler MB. A Predictive Metabolic Signature for the Transition From Gestational Diabetes Mellitus to Type 2 Diabetes. Diabetes. 2016 Sep;65(9):2529-39. doi: 10.2337/db15-1720. Epub 2016 Jun 23.
- Background: PubMed 28089710Bhupathiraju SN, Hu FB. One (small) step towards precision nutrition by use of metabolomics. Lancet Diabetes Endocrinol. 2017 Mar;5(3):154-155. doi: 10.1016/S2213-8587(17)30007-4. Epub 2017 Jan 13. No abstract available.
- BackgroundInstitute for Public Health [IPH]. 2015. Vol. II: Non-communicable diseases, risk factors and other health problems. National Health and Morbidity Survey (NHMS 2015). Kuala Lumpur, Malaysia: IPH, Ministry of Health.
- BackgroundMalaysian Endocrine & Metabolic Society [MEMS] and Ministry of Health [MOH] Malaysia. 2015. Management of type 2 diabetes mellitus (5th Edition). Kuala Lumpur, Malaysia: MEMS & MOH.
- Background: PubMed 24450389Nielsen KK, Kapur A, Damm P, de Courten M, Bygbjerg IC. From screening to postpartum follow-up - the determinants and barriers for gestational diabetes mellitus (GDM) services, a systematic review. BMC Pregnancy Childbirth. 2014 Jan 22;14:41. doi: 10.1186/1471-2393-14-41.
- Background: PubMed 28091346O'Gorman A, Brennan L. The role of metabolomics in determination of new dietary biomarkers. Proc Nutr Soc. 2017 Aug;76(3):295-302. doi: 10.1017/S0029665116002974. Epub 2017 Jan 16.
- Background: PubMed 28513624Tee ES, Yap RWK. Type 2 diabetes mellitus in Malaysia: current trends and risk factors. Eur J Clin Nutr. 2017 Jul;71(7):844-849. doi: 10.1038/ejcn.2017.44. Epub 2017 May 17.
- Background: PubMed 22987062Tobias DK, Hu FB, Chavarro J, Rosner B, Mozaffarian D, Zhang C. Healthful dietary patterns and type 2 diabetes mellitus risk among women with a history of gestational diabetes mellitus. Arch Intern Med. 2012 Nov 12;172(20):1566-72. doi: 10.1001/archinternmed.2012.3747.
- Background: PubMed 24828694Zhang C, Hu FB, Olsen SF, Vaag A, Gore-Langton R, Chavarro JE, Bao W, Yeung E, Bowers K, Grunnet LG, Sherman S, Kiely M, Strom M, Hansen S, Liu A, Mills J, Fan R; DWH study team. Rationale, design, and method of the Diabetes & Women's Health study--a study of long-term health implications of glucose intolerance in pregnancy and their determinants. Acta Obstet Gynecol Scand. 2014 Nov;93(11):1123-30. doi: 10.1111/aogs.12425. Epub 2014 Jun 9.
- Background: PubMed 12351492Kim C, Newton KM, Knopp RH. Gestational diabetes and the incidence of type 2 diabetes: a systematic review. Diabetes Care. 2002 Oct;25(10):1862-8. doi: 10.2337/diacare.25.10.1862.
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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
Farah Yasmin Hasbullah, MSc principal investigator
Universiti Putra Malaysia
Geeta Appannah, 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?
An observational study of Type 2 Diabetes and Gestational Diabetes, 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 9 Dec 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barakatun Nisak Mohd. Yusof, PhD (+603-97692606, bnisak@upm.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutritype signature of T2DM risks in women post-GDM (time frame: Through study completion, an average of 1 year). 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 NCT04190199, which also lists 10 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 9 Dec 2019.