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Alkaline Diet for Insulin Sensitivity (ADIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02501343
Recruitment Status : Completed
First Posted : July 17, 2015
Last Update Posted : March 7, 2017
Sponsor:
Information provided by (Responsible Party):
Dorit Samocha-Bonet, Garvan Institute of Medical Research

Tracking Information
First Submitted Date  ICMJE July 13, 2015
First Posted Date  ICMJE July 17, 2015
Last Update Posted Date March 7, 2017
Actual Study Start Date  ICMJE March 2015
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2017)
Changes in venous blood pH [ Time Frame: Baseline (fasting) and 3 hours post meal ]
The investigators aim is to determine whether venous blood pH decreases after a high acid load meal, and whether this effect is attenuated by administration of sodium bicarbonate prior to a mixed meal study
Original Primary Outcome Measures  ICMJE
 (submitted: July 15, 2015)
  • Change in glucose homeostasis [ Time Frame: ADIS: 4 week intervention (sodium bicarbonate administration), ADIS Meal: 3 hour meal study x 2 per participant, 1 week apart (with sodium bicarbonate and placebo) ]
    ADIS: Changes in the glucose infusion rate (marker of insulin sensitivity) will be measured at the 4 week hyperinsulinaemic euglycaemic clamp study compared to the baseline study, after daily sodium bicarbonate administration. ADIS Meal: Changes in glucose and insulin excursion will be measured during a 3 hour meal study with sodium bicarbonate compared to placebo
  • Changes in venous blood pH [ Time Frame: ADIS: 4 week intervention (sodium bicarbonate administration), ADIS Meal: 3 hour meal study x 2 per participant, 1 week apart (with sodium bicarbonate and placebo) ]
    ADIS: The investigators aim to determine whether venous blood pH is lower in overweight/obese insulin resistant men, and whether daily sodium bicarbonate administration causes an upward shift in plasma pH. ADIS meal: The investigators aim to determine whether venous blood pH decreases after a high acid load meal, and whether this effect is attenuated by administration of sodium bicarbonate prior to a mixed meal study
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2017)
  • Changes in glycemic response to the meal [ Time Frame: Baseline (fasting) and 3 hours post meal ]
    Postprandial glucose excursion will be compared between sodium bicarbonate and placebo
  • Changes in insulin response to the meal [ Time Frame: Baseline (fasting) and 3 hours post meal ]
    Postprandial insulin excursion will be compared between sodium bicarbonate and placebo
  • Changes in arterial stiffness [ Time Frame: Baseline (fasting) and 3 hours post meal ]
    Postprandial arterial stiffness (measured by the augmentation index derived from Sphygmocore, Atcor Medical, Australia) will be compared between sodium bicarbonate and placebo
  • Changes in hunger and satiety scores [ Time Frame: Baseline (fasting) and 3 hours post meal ]
    Postprandial hunger and satiety will be compared between sodium bicarbonate and placebo
Original Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2015)
  • Change in insulin signalling in muscle [ Time Frame: ADIS: 4 week intervention (sodium bicarbonate intervention) ]
    Changes in mediators of the insulin signalling cascade in muscle biopsies
  • Changes in arterial stiffness [ Time Frame: ADIS: 4 week intervention (sodium bicarbonate administration), ADIS Meal: 3 hour meal study x 2 per participant, 1 week apart (with sodium bicarbonate and placebo) ]
    Arterial stiffness will be measured at baseline and at steady state during 2.5 hour hyperinsulinemic clamp. ADIS Meal: Arterial stiffness will be measured every 30 minutes during the 3 hour meal study.
  • Incretin levels [ Time Frame: ADIS Meal: 3 hour meal study x 2 per participant, 1 week apart (with sodium bicarbonate and placebo) ]
    Baseline and postprandial levels of GLP-1, PYY, GIP will be measured
  • Changes in metabolic flexibility [ Time Frame: ADIS: 4 week intervention (sodium bicarbonate administration) ]
    Indirect calorimetry will be used to measure respiratory quotient at baseline (fasting) and in response to hyperinsulinemia
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Alkaline Diet for Insulin Sensitivity
Official Title  ICMJE Alkaline Diet for Insulin Sensitivity
Brief Summary

The purpose of this study is to test the effect of increasing the body pH acutely with an alkaline medication (sodium bicarbonate, NaHCO3, sodibic) on glucose metabolism post meal in non diabetic subjects with normal renal function.

The investigators aim to determine whether there is an acute reduction in venous blood pH following a typical Western-style (high acid load) breakfast in healthy men and women, and whether this effect is attenuated by the concurrent administration of an alkaline medication. The effect on glucose metabolism, hunger/satiety and arterial stiffness post meal will be assessed.

Detailed Description

The aim of the study is to test the effect of increasing the body pH acutely with an alkali (NaHCO3) prior to a high acid load meal on glucose metabolism in non-diabetic men and women.

This is a double-blind placebo-controlled randomised study with a crossover design.

Study Procedures:

Two (2) meal studies will be performed 1 to 2 weeks apart. Studies will include collecting fasting blood to assess circulating glucose, insulin, C-peptide, free fatty acids, glucagon-like peptide-1, acid/base markers, including electrolytes (EUC) and venous blood pH. Participants will then be either administered sodibic (1680 mg) or matching placebo and a standardised Western style/high acid load meal. Investigators and participants will be blinded to the intervention. Blood will be drawn every 15 min in the first hour and then every 30 min for 3 hours in total. Arterial stiffness and appetite score will be evaluated at ½ h intervals.

Sample size: 30

sample size calculation: To detect a difference in area under the curve (AUC) of venous blood pH with a paired crossover design, 32 individuals will be required with statistical power 1-β>0.8 (allowing for drop-out).

statistical considerations: Differences between AUC of outcome measures post sodium bicarbonate vs. placebo will be tested using paired t-tests. Two-way repeated measure ANOVA tests will be conducted to assess differences in the response to the meal with sodium bicarbonate vs. placebo.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Dysglycemia
  • Type 2 Diabetes Mellitus
Intervention  ICMJE
  • Drug: Sodium Bicarbonate Oral Capsule
    Sodium bicarbonate 1680 mg will be administered prior to the meal
    Other Name: Sodibic capsules (Aspen Australia, NSW, Australia)
  • Drug: Placebo
    Sodibic-matching placebo (Stenlake Compounding Chemist, NSW, Australia) will be administered prior to the meal on a different day 1 to 2 weeks apart
Study Arms  ICMJE
  • Experimental: Sodium bicarbonate
    High acid load meal (Western style meal) with Sodium bicarbonate (Sodibic 840mg*2)
    Intervention: Drug: Sodium Bicarbonate Oral Capsule
  • Placebo Comparator: Placebo
    High acid load meal (Western style meal) with sodibic-matching placebo
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 5, 2017)
32
Original Estimated Enrollment  ICMJE
 (submitted: July 15, 2015)
30
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age range: 22-65
  • Disease status: Healthy.
  • Laboratory parameters: Fasting plasma glucose <7 mmol/L, HbA1c <6.5% (48 mmol/mol).
  • Willingness to give written informed consent and willingness to participate and comply with the study.

Exclusion Criteria:

  • Individuals with a personal history of diabetes, hypertension, cardiovascular disease, kidney disease, respiratory disease or inflammatory disease.
  • Individuals treated with medications known to affect insulin sensitivity.
  • Individuals with fasting plasma glucose ≥7 mmol/L, HbA1c ≥6.5% (48 mmol/mol).
  • Individuals with an unstable body weight in the past 3 months (+/- 2 kg or more).
  • Individuals with a history of a psychological illness or condition that may interfere with the participant's ability to understand the requirements of the study.
  • Individuals who smoke.
  • Individuals who consume more than 40 g of alcohol daily.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02501343
Other Study ID Numbers  ICMJE ADIS (SVH 14/157)
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dorit Samocha-Bonet, Garvan Institute of Medical Research
Study Sponsor  ICMJE Garvan Institute of Medical Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dorit Samocha-Bonet, BSc(Hons) MSc(Hons) PhD Garvan Institute of Medical Research
PRS Account Garvan Institute of Medical Research
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP