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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

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.


Condition or disease Intervention/treatment Phase
Dysglycemia Type 2 Diabetes Mellitus Drug: Sodium Bicarbonate Oral Capsule Drug: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Alkaline Diet for Insulin Sensitivity
Actual Study Start Date : March 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sodium bicarbonate
High acid load meal (Western style meal) with Sodium bicarbonate (Sodibic 840mg*2)
Drug: Sodium Bicarbonate Oral Capsule
Sodium bicarbonate 1680 mg will be administered prior to the meal
Other Name: Sodibic capsules (Aspen Australia, NSW, Australia)

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02501343


Locations
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Australia, New South Wales
Garvan Institute of Medical Research
Darlinghurst, New South Wales, Australia, 2010
Sponsors and Collaborators
Garvan Institute of Medical Research
Investigators
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Principal Investigator: Dorit Samocha-Bonet, BSc(Hons) MSc(Hons) PhD Garvan Institute of Medical Research
Publications:

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Responsible Party: Dorit Samocha-Bonet, Leader, Clinical Insulin Resistance Group, Diabetes and Metabolism Division, Garvan Institute of Medical Research
ClinicalTrials.gov Identifier: NCT02501343    
Other Study ID Numbers: ADIS (SVH 14/157)
First Posted: July 17, 2015    Key Record Dates
Last Update Posted: March 7, 2017
Last Verified: March 2017

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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
Keywords provided by Dorit Samocha-Bonet, Garvan Institute of Medical Research:
Glucose metabolism
Potential renal acid load
Postprandial glycemia
Body acid-base homeostasis
Sodium bicarbonate
Additional relevant MeSH terms:
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Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Hyperinsulinism