An interventional study of Sodium Bicarbonate Oral Capsule and Placebo in Dysglycemia and Type 2 Diabetes Mellitus, sponsored by Garvan Institute of Medical Research. Completed at 1 site in Australia. Open to participants aged 22 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-07.
Sponsored by Garvan Institute of Medical Research · Not applicable, Interventional, and Prevention
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.
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.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 32 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Garvan Institute of Medical Research is the lead sponsor of 10 studies on the registry; none are open to participants now.
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Exclusion Criteria:
High acid load meal (Western style meal) with Sodium bicarbonate (Sodibic 840mg\*2)
Drug: Sodium Bicarbonate Oral Capsule
High acid load meal (Western style meal) with sodibic-matching placebo
Drug: Placebo
Sodium bicarbonate 1680 mg will be administered prior to the meal
Also known as: Sodibic capsules (Aspen Australia, NSW, Australia)
Sodibic-matching placebo (Stenlake Compounding Chemist, NSW, Australia) will be administered prior to the meal on a different day 1 to 2 weeks apart
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
Time frame: Baseline (fasting) and 3 hours post meal
Changes in glycemic response to the meal
Postprandial glucose excursion will be compared between sodium bicarbonate and placebo
Time frame: Baseline (fasting) and 3 hours post meal
Changes in insulin response to the meal
Postprandial insulin excursion will be compared between sodium bicarbonate and placebo
Time frame: Baseline (fasting) and 3 hours post meal
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
Time frame: Baseline (fasting) and 3 hours post meal
Changes in hunger and satiety scores
Postprandial hunger and satiety will be compared between sodium bicarbonate and placebo
Time frame: Baseline (fasting) and 3 hours post meal
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Garvan Institute of Medical Research