Postprandial Metabolites of Meal Challenge Test in Diabetes State

NCT ID: NCT04234763

Last Updated: 2020-01-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2020-06-30

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

T2D patients

T2D patients (n=24) will be randomized to high GI and low GI MCT randomly.

Group Type: EXPERIMENTAL

Strategies to lower postprandial hyperglycemia in T2D patients

Intervention Type: BEHAVIORAL

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.

Healthy individuals

Healthy individuals (n=24) will be randomized to high GI MCT only.

Group Type: ACTIVE_COMPARATOR

Control group

Intervention Type: BEHAVIORAL

Assess nutritional status and no active intervention is conducted.

Interventions

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.

Intervention Type: BEHAVIORAL

Control group

Assess nutritional status and no active intervention is conducted.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universiti Putra Malaysia

OTHER

Sponsor Role: lead

Responsible Party

Barakatun Nisak Bt Mohd Yusof

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Assoc. Prof. Dr. Barakatun Nisak

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine and Health Sciences, Universiti Putra Malaysia

Locations

Universiti Putra Malaysia

Serdang, Selangor, Malaysia

Countries

Malaysia

Other Identifiers

9613400

Identifier Type: -

Identifier Source: org_study_id