Postprandial Metabolites of Meal Challenge Test in Diabetes State

NCT04234763 | Unknown

• 1 other identifier: 9613400
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Type2 Diabetes; Postprandial Hyperglycemia

Keywords

Glycemic Index; NMR metabolomics; Postmeal glucose

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• Postprandial 1H-NMR metabolites

  Between T2D and healthy individuals measured by blood plasma using 1H-NMR spectrometer

  During the 4 hour meal challenge

Secondary Outcomes (5)

• Body mass index (BMI)

  Before and after the 14-days intervention

• Waist circumference

  Before and after the 14-days intervention

• Lipid profile

  Before and after the 14-days intervention

• Dietary glycemic index (GI)

  Before and after the 14-days intervention

• Dietary Glycemic load(GL)

  Before and after the 14-days intervention

Study Arms (2)

T2D patients

EXPERIMENTAL

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

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.

Behavioral: Control group

Interventions

Strategies to lower postprandial hyperglycemia in T2D patients 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.

T2D patients

Control group BEHAVIORAL

Assess nutritional status and no active intervention is conducted.

Healthy individuals

Eligibility Criteria

• Age: 35 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Putra Malaysia: lead

Study Sites (1)

Universiti Putra Malaysia

Serdang, Selangor, 43400, Malaysia

Location

MeSH Terms

Conditions

Hyperglycemia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Assoc. Prof. Dr. Barakatun Nisak

  Faculty of Medicine and Health Sciences, Universiti Putra Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: January 21, 2020
• Study Start: August 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: June 1, 2020
• Last Updated: January 21, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)