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Postprandial Metabolites of Meal Challenge Test in Diabetes State

NCT04234763 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2020-01-21

No results posted yet for this study

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.

Conditions

  • Type2 Diabetes
  • Postprandial Hyperglycemia

Interventions

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.

BEHAVIORAL

Control group

Assess nutritional status and no active intervention is conducted.

Sponsors & Collaborators

  • Universiti Putra Malaysia

    lead OTHER

Principal Investigators

  • Assoc. Prof. Dr. Barakatun Nisak · Faculty of Medicine and Health Sciences, Universiti Putra Malaysia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
35 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-01
Primary Completion
2020-01-31
Completion
2020-06-30

Countries

  • Malaysia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04234763 on ClinicalTrials.gov