Role of Glycaemic Index and High Protein Meal in Response of Blood Biomarkers for Pre-diabetes
Condition: Pre Diabetes
MeSH terms: Diabetes Mellitus; Prediabetic State; Glucose Intolerance
Study type: Interventional

Summary: 
      This study aims to demonstrate the effectiveness of increased protein ingestion, particularly
      when coupled with a low glycaemic index (GI) to reduce biomarkers related to high risk of
      diabetes.
    

Detailed description: 
      A randomized cross-over study and subjects will be randomized to take either the high GI or
      low GI meal. The sequence of the meal will be generated using an online randomiser
      generator.During screening administer informed consent.Measure height, weight, waist and hip
      circumference.Blood draw: Two fingerpricks, 5 minutes apart. 1 X 10ml red tube top to prepare
      serum. Serum and red platelets into separate microtubes. Serum will be used to analyse
      fasting blood glucose, lipid profile, C-Reactive Protein (CPR), insulin and apolipoprotein.
      Red platelets will be stored separately for DNA genotyping. During the study visits,On Day 1,
      subjects will come to the Centre at around 4:00 pm to have the continuous glucose monitoring
      (CGMS) system inserted. CGMS will be used to measure 24 hour blood glucose concentrations.
      The sensor records interstitial blood glucose concentrations every five minutes. This will
      involve the insertion of a small sensor under the skin in the abdomen, which will be carried
      out by using a device that produces minimal pain and discomfort.Subjects will have to wait in
      the laboratory for one hour after insertion for the sensor to be stabilized. After one hour
      the inserted CGMS sensor will be calibrated against a manual finger-prick blood glucose
      sample.Manual calibration using finger-prick blood samples will need to be carried out before
      every meal and before bed in the night. The calibrations before dinner and bed will have to
      be carried out by the subjects at home.Therefore, the subjects will be provided with a
      finger-prick blood glucose test kit to take home and instructed on how to correctly use it
      and measure blood glucose values. Subjects will then consume the standardised dinner at
      around 7pm.Subjects will be asked to fast overnight and instructed to avoid eating or
      drinking anything, except water, after 10pm. Subjects will arrived between 8.00am and 8.30am
      the following morning. Baseline blood samples will be collected. A venous cannula will be
      inserted and a fasting blood sample collected. Baseline basal metabolic rate will be measured
      using hood-ventilated indirect calorimetry for 30mins during fasting. Subjects will then
      consume the test meal. Further venous blood samples will be collected at regular intervals
      for up to 4hours postprandial. After meal, subjects will enter the hood-ventilated indirect
      calorimetry and measure post-prandial respiratory quotient for 4 hours. A medium GI lunch
      will then be provided and the subject can either stay in the centre or return to the centre 4
      hours after lunch to remove the CGMS.
    

Intervention name(s): High Glycemic Index; Low Glycemic Index
Intervention type(s): Other; Other
Intervention description(s): High Glycemic Index Food; Low Glycemic Index Food
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized crossover study
Masking: None (Open Label)
Primary purpose: Other