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Alkaline Diet for Insulin Sensitivity (ADIS)

Primary Purpose

Dysglycemia, Type 2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Sodium Bicarbonate Oral Capsule
Placebo
Sponsored by
Garvan Institute of Medical Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dysglycemia focused on measuring Glucose metabolism, Potential renal acid load, Postprandial glycemia, Body acid-base homeostasis, Sodium bicarbonate

Eligibility Criteria

22 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Garvan Institute of Medical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Sodium bicarbonate

Placebo

Arm Description

High acid load meal (Western style meal) with Sodium bicarbonate (Sodibic 840mg*2)

High acid load meal (Western style meal) with sodibic-matching placebo

Outcomes

Primary Outcome Measures

Changes in venous blood pH
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

Secondary Outcome Measures

Changes in glycemic response to the meal
Postprandial glucose excursion will be compared between sodium bicarbonate and placebo
Changes in insulin response to the meal
Postprandial insulin excursion will be compared between sodium bicarbonate and placebo
Changes in arterial stiffness
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
Postprandial hunger and satiety will be compared between sodium bicarbonate and placebo

Full Information

First Posted
July 13, 2015
Last Updated
March 5, 2017
Sponsor
Garvan Institute of Medical Research
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1. Study Identification

Unique Protocol Identification Number
NCT02501343
Brief Title
Alkaline Diet for Insulin Sensitivity
Acronym
ADIS
Official Title
Alkaline Diet for Insulin Sensitivity
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Garvan Institute of Medical Research

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysglycemia, Type 2 Diabetes Mellitus
Keywords
Glucose metabolism, Potential renal acid load, Postprandial glycemia, Body acid-base homeostasis, Sodium bicarbonate

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sodium bicarbonate
Arm Type
Experimental
Arm Description
High acid load meal (Western style meal) with Sodium bicarbonate (Sodibic 840mg*2)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
High acid load meal (Western style meal) with sodibic-matching placebo
Intervention Type
Drug
Intervention Name(s)
Sodium Bicarbonate Oral Capsule
Other Intervention Name(s)
Sodibic capsules (Aspen Australia, NSW, Australia)
Intervention Description
Sodium bicarbonate 1680 mg will be administered prior to the meal
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Sodibic-matching placebo (Stenlake Compounding Chemist, NSW, Australia) will be administered prior to the meal on a different day 1 to 2 weeks apart
Primary Outcome Measure Information:
Title
Changes in venous blood pH
Description
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
Time Frame
Baseline (fasting) and 3 hours post meal
Secondary Outcome Measure Information:
Title
Changes in glycemic response to the meal
Description
Postprandial glucose excursion will be compared between sodium bicarbonate and placebo
Time Frame
Baseline (fasting) and 3 hours post meal
Title
Changes in insulin response to the meal
Description
Postprandial insulin excursion will be compared between sodium bicarbonate and placebo
Time Frame
Baseline (fasting) and 3 hours post meal
Title
Changes in arterial stiffness
Description
Postprandial arterial stiffness (measured by the augmentation index derived from Sphygmocore, Atcor Medical, Australia) will be compared between sodium bicarbonate and placebo
Time Frame
Baseline (fasting) and 3 hours post meal
Title
Changes in hunger and satiety scores
Description
Postprandial hunger and satiety will be compared between sodium bicarbonate and placebo
Time Frame
Baseline (fasting) and 3 hours post meal

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dorit Samocha-Bonet, BSc(Hons) MSc(Hons) PhD
Organizational Affiliation
Garvan Institute of Medical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Garvan Institute of Medical Research
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia

12. IPD Sharing Statement

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Alkaline Diet for Insulin Sensitivity

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