Postprandial Metabolites of Meal Challenge Test in Diabetes State

Type2 Diabetes Clinical Trial

Official title:

Metabolomics Determinant of Postprandial Metabolism Following Meal-Challenge Test in Diabetes State Using NMR-based Metabolomics Approach

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04234763
• Other study ID #: 9613400
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: June 2020

Study information

• Verified date: January 2020
• Source: Universiti Putra Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 48
• Est. completion date: June 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 50 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Hyperglycemia
• Postprandial Hyperglycemia
• Type2 Diabetes

Intervention

Behavioral:
• Strategies to lower postprandial hyperglycemia in T2D patients
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 group
Assess nutritional status and no active intervention is conducted.

Locations

Country	Name	City	State
Malaysia	Universiti Putra Malaysia	Serdang	Selangor

Sponsors (1)

Lead Sponsor	Collaborator
Universiti Putra Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial glucose	Between low GI and high GI meal challenge measured by blood plasma using Abbott Architect c16000 analyser	Change from baseline and after 14-days intervention
Primary	Postprandial insulin	Between low GI and high GI meal challenge measured by blood serum using COBAS e411 analyzer	Change from baseline and after 14-days intervention
Primary	Postprandial GLP-1	Between low GI and high GI meal challenge measured by blood plasma using total ELISA kit	Change from baseline and after 14-days intervention
Primary	1H-NMR metabolites	Between low GI and high GI meal challenge measured by blood plasma using 1H-NMR spectrometer	Change from baseline and after 14-days intervention
Primary	Postprandial 1H-NMR metabolites	Between T2D and healthy individuals measured by blood plasma using 1H-NMR spectrometer	During the 4 hour meal challenge
Secondary	Body mass index (BMI)	Measured by weight change using Tanita digital weighing scale	Before and after the 14-days intervention
Secondary	Waist circumference	Using measuring tape	Before and after the 14-days intervention
Secondary	Lipid profile	Measured by blood plasma using Abbott Architect c16000 analyser	Before and after the 14-days intervention
Secondary	Dietary glycemic index (GI)	Between T2D and healthy individuals measured using Dietary History Questionnaire	Before and after the 14-days intervention
Secondary	Dietary Glycemic load(GL)	Between T2D and healthy individuals measured using Dietary History Questionnaire	Before and after the 14-days intervention