Type2 DiabetesNCT04234763
Postprandial Metabolites of Meal Challenge Test in Diabetes State
A study testing Strategies to lower postprandial hyperglycemia in T2D patients in people with Type2 Diabetes and Postprandial Hyperglycemia, run by Universiti Putra Malaysia at 1 site in Malaysia.
Trial summary
Postprandial hyperglycemia is a hallmark feature of Type 2 Diabetes Mellitus (T2D), and persistent elevated glycemic level has shown to be strongly associated with oxidative stress, and a risk factor for cardiovascular disease (CVD). Read more about this study
- Who is it for?
- Ages 35 to 50 years
- Conditions the study is for
- Type2 Diabetes, Postprandial Hyperglycemia
- What is being tested?
- Strategies to lower postprandial hyperglycemia in T2D patients
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Aug 2019to Jun 2020
- 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 35 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- BMI 18.5-35.0 kg/m²
- Glycemic control (HbA1c level 6.5 - 10.0%)
- On stabilised oral-antidiabetic drug (OAD) : metformin, sulphonylureas, SGLT2 inhibitors
- Estimated glomerular filtration rate (GFR) >60ml/min
- No clinically significant cardiovascular, renal or liver disease
Who cannot join
- Smokers
- Pregnant and lactating women
- Food allergies or intolerances
- On weight loss diet
- On insulin therapy
- On OAD: DPP-4 inhibitors, GLP-1 receptor agonists, acarbose
Show all 9Show fewer
- Anemia (Hb <10g/dL)
- On regular use of hormones or anti-inflammatory medication (aspirin, corticosteroid)
- Suggestive indicators for impaired thyroid (high T2H level) or liver function
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Metabolomics Determinant of Postprandial Metabolism Following Meal-Challenge Test in Diabetes State Using NMR-based Metabolomics Approach
Postprandial hyperglycemia is a hallmark feature of Type 2 Diabetes Mellitus (T2D), and persistent elevated glycemic level has shown to be strongly associated with oxidative stress, and a risk factor for cardiovascular disease (CVD). In Malaysia, the glycemic control is poor and patients with T2D commonly experiencing persistent postprandial hyperglycemia (12.7 mmol/L). A low glycemic index (GI) meal has been reported to reduce postprandial glycemia and insulin concentration in patients with T2D. Metabolomics technique can be used to identify comprehensive metabolites in response to different diet. Till date, local scientific data documented on the role and interaction between diet and metabolites for the Malaysian patients with T2D is unknown. This study is to determine the postprandial metabolomic effect of low and high GI meals in patients with T2D using the NMR-based metabolomics approach. Then, patients with T2D will be assigned for 14 days of chronic feeding trial intervention. This study will help to establish local baseline data and understand the impact of meal-patterns on metabolic and metabolite at postprandial responses.
Read the detailed description
Despite targeting to optimize fasting blood glucose and lowering HbA1c level, postprandial hyperglycemia needs to be highlighted in the management of Type 2 Diabetes Mellitus (T2D). Postprandial hyperglycemia is the rapid and significant rise in blood glucose level above 7.8 mmol/L 2 hour after meal ingestion. It is strongly associated with oxidative stress and a risk factor for cardiovascular disease (CVD).
In Malaysia, the glycemic control is poor, and patients with T2D commonly experiencing persistent hyperglycemia (12.7 mmol/L), which is the highest concentration in South East Asia region. Nonetheless, a low glycemic index (GI) meal has been reported to reduce postprandial glycemia and insulin concentration in patients with T2D but the metabolite responsiveness following low GI meal is not studied yet. The study of the postprandial state is imperative as it reveals multiple aspects of metabolic health that would not be apparent from solely studying the fasting parameters.
Hence, the objective of this study is to determine the postprandial metabolomic effects of low and high GI meals in patients with T2D using the NMR-based metabolomics approach. Then, the postprandial metabolic response and metabolomic profiles before and after the 14 days chronic feeding trial intervention will be determined and compared. The calculated sample size was 24 patients with T2D and 24 healthy individuals. The study design for meal challenge test (MCT) is a single-blinded, randomized crossover trial with 1-week washout period; whereas a case-control design will be used to compare metabolomic profiles of patients with T2D and healthy individuals.
The MCT model is designed to be high GI (63) and low GI (46) with similar caloric value. During the test day, participants are required to consume the meal within 15 minutes and the blood sample will be taken at the following time points: 0min (fasting), 30, 60, 120, 180 and 240 min. Meanwhile, the urine sample will also be collected at 0, 60 and 240 min accordingly.
The blood sample will be analyzed for blood glucose, insulin, GLP-1, and metabolites; while the urine sample will be analyzed for metabolites. The findings of this study are able to provide fundamental data on metabolic responsiveness of T2D patients following specific meal-plan tailored to Malaysian meal pattern using NMR-based metabolomics approach. Besides, this study is able to establish a local baseline data of postprandial metabolite profiles of patients with T2D following a specific meal plan. At the same time, this study contributes insight to improve diabetes meal-plan that is friendly to postprandial metabolic perturbations.
- Conditions
- Type2 Diabetes, Postprandial Hyperglycemia
- Being tested
- Strategies to lower postprandial hyperglycemia in T2D patients, Control group
- Keywords
- Glycemic Index, NMR metabolomics, Postmeal glucose
- Medical subject headings
- Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strategies to lower postprandial hyperglycemia in T2D patientsBehavioural
T2D patients will undergo a 14-day chronic feeding trial intervention where the strategies to lower postprandial hyperglycemia will be educated. For example, to control portion of carbohydrate, incorporate low GI food and diabetes-specific formula, promote physical activity and practice consistent meal timing. After that, patients will undergo MCT again to evaluate the difference before and after the intervention.
Control groupBehavioural
Assess nutritional status and no active intervention is conducted.
| Study group | Role | What they receive |
|---|---|---|
| T2D patients | Experimental | T2D patients (n=24) will be randomized to high GI and low GI MCT randomly. Receives: Behavioral: Strategies to lower postprandial hyperglycemia in T2D patients |
| Healthy individuals | Active comparator | Healthy individuals (n=24) will be randomized to high GI MCT only. Receives: Behavioral: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial glucose
Between low GI and high GI meal challenge measured by blood plasma using Abbott Architect c16000 analyser
Measured: Change from baseline and after 14-days intervention
Postprandial insulin
Between low GI and high GI meal challenge measured by blood serum using COBAS e411 analyzer
Measured: Change from baseline and after 14-days intervention
Postprandial GLP-1
Between low GI and high GI meal challenge measured by blood plasma using total ELISA kit
Measured: Change from baseline and after 14-days intervention
1H-NMR metabolites
Between low GI and high GI meal challenge measured by blood plasma using 1H-NMR spectrometer
Measured: Change from baseline and after 14-days intervention
Postprandial 1H-NMR metabolites
Between T2D and healthy individuals measured by blood plasma using 1H-NMR spectrometer
Measured: During the 4 hour meal challenge
Secondary outcomes (5)
Body mass index (BMI)
Measured by weight change using Tanita digital weighing scale
Measured: Before and after the 14-days intervention
Waist circumference
Using measuring tape
Measured: Before and after the 14-days intervention
Lipid profile
Measured by blood plasma using Abbott Architect c16000 analyser
Measured: Before and after the 14-days intervention
Dietary glycemic index (GI)
Between T2D and healthy individuals measured using Dietary History Questionnaire
Measured: Before and after the 14-days intervention
Dietary Glycemic load(GL)
Between T2D and healthy individuals measured using Dietary History Questionnaire
Measured: Before and after the 14-days intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start1 Aug 2019
- Primary completionJan 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The meal challenge test (MCT) models are designed to be high glycemic index (GI) (GI=63, GL=25) and low GI meal (GI=46, GL=16), isocaloric (300kcal) with identical macronutrient distribution. The meals will be prepared on the morning of the test, portioned by weighing and served warm.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barakatun Nisak Bt Mohd Yusof, Universiti Putra Malaysia
- Investigators
- Assoc. Prof. Dr. Barakatun Nisak, Principal investigator, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04234763
- Sponsor's protocol ID
- 9613400
- Status last verified
- Jan 2020
- First submitted
- 3 Dec 2019
- Last updated
- 21 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolomics Determinant of Postprandial Metabolism Following Meal-Challenge Test in Diabetes State Using NMR-based Metabolomics Approach
- ClinicalTrials.gov ID
- NCT04234763
- Acronym / sponsor ID
- 9613400
- Conditions
- Type2 Diabetes, Postprandial Hyperglycemia
- Keywords
- Glycemic Index, NMR metabolomics, Postmeal glucose
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 21 Jan 2020 (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.
Postprandial hyperglycemia is a hallmark feature of Type 2 Diabetes Mellitus (T2D), and persistent elevated glycemic level has shown to be strongly associated with oxidative stress, and a risk factor for cardiovascular disease (CVD). In Malaysia, the glycemic control is poor and patients with T2D commonly experiencing persistent postprandial hyperglycemia (12.7 mmol/L). A low glycemic index (GI) meal has been reported to reduce postprandial glycemia and insulin concentration in patients with T2D. Metabolomics technique can be used to identify comprehensive metabolites in response to different diet. Till date, local scientific data documented on the role and interaction between diet and metabolites for the Malaysian patients with T2D is unknown. This study is to determine the postprandial metabolomic effect of low and high GI meals in patients with T2D using the NMR-based metabolomics approach. Then, patients with T2D will be assigned for 14 days of chronic feeding trial intervention. This study will help to establish local baseline data and understand the impact of meal-patterns on metabolic and metabolite at postprandial responses.
Detailed description
Despite targeting to optimize fasting blood glucose and lowering HbA1c level, postprandial hyperglycemia needs to be highlighted in the management of Type 2 Diabetes Mellitus (T2D). Postprandial hyperglycemia is the rapid and significant rise in blood glucose level above 7.8 mmol/L 2 hour after meal ingestion. It is strongly associated with oxidative stress and a risk factor for cardiovascular disease (CVD).
In Malaysia, the glycemic control is poor, and patients with T2D commonly experiencing persistent hyperglycemia (12.7 mmol/L), which is the highest concentration in South East Asia region. Nonetheless, a low glycemic index (GI) meal has been reported to reduce postprandial glycemia and insulin concentration in patients with T2D but the metabolite responsiveness following low GI meal is not studied yet. The study of the postprandial state is imperative as it reveals multiple aspects of metabolic health that would not be apparent from solely studying the fasting parameters.
Hence, the objective of this study is to determine the postprandial metabolomic effects of low and high GI meals in patients with T2D using the NMR-based metabolomics approach. Then, the postprandial metabolic response and metabolomic profiles before and after the 14 days chronic feeding trial intervention will be determined and compared. The calculated sample size was 24 patients with T2D and 24 healthy individuals. The study design for meal challenge test (MCT) is a single-blinded, randomized crossover trial with 1-week washout period; whereas a case-control design will be used to compare metabolomic profiles of patients with T2D and healthy individuals.
The MCT model is designed to be high GI (63) and low GI (46) with similar caloric value. During the test day, participants are required to consume the meal within 15 minutes and the blood sample will be taken at the following time points: 0min (fasting), 30, 60, 120, 180 and 240 min. Meanwhile, the urine sample will also be collected at 0, 60 and 240 min accordingly.
The blood sample will be analyzed for blood glucose, insulin, GLP-1, and metabolites; while the urine sample will be analyzed for metabolites. The findings of this study are able to provide fundamental data on metabolic responsiveness of T2D patients following specific meal-plan tailored to Malaysian meal pattern using NMR-based metabolomics approach. Besides, this study is able to establish a local baseline data of postprandial metabolite profiles of patients with T2D following a specific meal plan. At the same time, this study contributes insight to improve diabetes meal-plan that is friendly to postprandial metabolic perturbations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The meal challenge test (MCT) models are designed to be high glycemic index (GI) (GI=63, GL=25) and low GI meal (GI=46, GL=16), isocaloric (300kcal) with identical macronutrient distribution. The meals will be prepared on the morning of the test, portioned by weighing and served warm.
| Arm | Type | Receives |
|---|---|---|
| T2D patients | Experimental | Behavioral: Strategies to lower postprandial hyperglycemia in T2D patientsT2D patients (n=24) will be randomized to high GI and low GI MCT randomly. |
| Healthy individuals | Active comparator | Behavioral: Control groupHealthy individuals (n=24) will be randomized to high GI MCT only. |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- BMI 18.5-35.0 kg/m²
- Glycemic control (HbA1c level 6.5 - 10.0%)
- On stabilised oral-antidiabetic drug (OAD) : metformin, sulphonylureas, SGLT2 inhibitors
- Estimated glomerular filtration rate (GFR) >60ml/min
- No clinically significant cardiovascular, renal or liver disease
Key exclusion criteria (9 listed)
- Smokers
- Pregnant and lactating women
- Food allergies or intolerances
- On weight loss diet
- On insulin therapy
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 |
|---|---|---|
| Strategies to lower postprandial hyperglycemia in T2D patientsT2D patients will undergo a 14-day chronic feeding trial intervention where the strategies to lower postprandial hyperglycemia will be educated. For example, to control portion of carbohydrate, incorporate low GI food and diabetes-specific formula, promote physical activity and practice consistent meal timing. After that, patients will undergo MCT again to evaluate the difference before and after the intervention. | Behavioural | T2D patients |
| Control groupAssess nutritional status and no active intervention is conducted. | Behavioural | Healthy individuals |
Primary outcome
Postprandial glucose
Time frame: Change from baseline and after 14-days intervention
Between low GI and high GI meal challenge measured by blood plasma using Abbott Architect c16000 analyser
Postprandial insulin
Time frame: Change from baseline and after 14-days intervention
Between low GI and high GI meal challenge measured by blood serum using COBAS e411 analyzer
Postprandial GLP-1
Time frame: Change from baseline and after 14-days intervention
Between low GI and high GI meal challenge measured by blood plasma using total ELISA kit
1H-NMR metabolites
Time frame: Change from baseline and after 14-days intervention
Between low GI and high GI meal challenge measured by blood plasma using 1H-NMR spectrometer
Postprandial 1H-NMR metabolites
Time frame: During the 4 hour meal challenge
Between T2D and healthy individuals measured by blood plasma using 1H-NMR spectrometer
5 secondary outcomes
Body mass index (BMI)
Time frame: Before and after the 14-days intervention
Waist circumference
Time frame: Before and after the 14-days intervention
Lipid profile
Time frame: Before and after the 14-days intervention
Dietary glycemic index (GI)
Time frame: Before and after the 14-days intervention
Dietary Glycemic load(GL)
Time frame: Before and after the 14-days intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2020.
- Individual participant dataSharing planned: No
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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.
Assoc. Prof. Dr. Barakatun Nisak principal investigator
Faculty of Medicine and Health Sciences, 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 Strategies to lower postprandial hyperglycemia in T2D patients in people with Type2 Diabetes and Postprandial Hyperglycemia, 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 5 inclusion and 9 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 21 Jan 2020. 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?
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?
Postprandial glucose (time frame: Change from baseline and after 14-days intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jan 2020.