NCT02501343

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 17, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 7, 2017

Status Verified

March 1, 2017

Enrollment Period

1.8 years

First QC Date

July 13, 2015

Last Update Submit

March 5, 2017

Conditions

DysglycemiaType 2 Diabetes Mellitus

Keywords

Glucose metabolismPotential renal acid loadPostprandial glycemiaBody acid-base homeostasisSodium bicarbonate

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline (fasting) and 3 hours post meal

Secondary Outcomes (4)

  • Changes in glycemic response to the meal

    Baseline (fasting) and 3 hours post meal

  • Changes in insulin response to the meal

    Baseline (fasting) and 3 hours post meal

  • Changes in arterial stiffness

    Baseline (fasting) and 3 hours post meal

  • Changes in hunger and satiety scores

    Baseline (fasting) and 3 hours post meal

Study Arms (2)

Sodium bicarbonate

EXPERIMENTAL

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

Drug: Sodium Bicarbonate Oral Capsule

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Sodium Bicarbonate Oral CapsuleDRUG

Sodium bicarbonate 1680 mg will be administered prior to the meal

Also known as: Sodibic capsules (Aspen Australia, NSW, Australia)
Sodium bicarbonate
PlaceboDRUG

Sodibic-matching placebo (Stenlake Compounding Chemist, NSW, Australia) will be administered prior to the meal on a different day 1 to 2 weeks apart

Placebo

Eligibility Criteria

Age22 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Garvan Institute of Medical Research

Darlinghurst, New South Wales, 2010, Australia

Location

Related Publications (15)

  • DeFronzo RA, Beckles AD. Glucose intolerance following chronic metabolic acidosis in man. Am J Physiol. 1979 Apr;236(4):E328-34. doi: 10.1152/ajpendo.1979.236.4.E328.

    PMID: 434194BACKGROUND

  • Fagherazzi G, Vilier A, Bonnet F, Lajous M, Balkau B, Boutron-Rualt MC, Clavel-Chapelon F. Dietary acid load and risk of type 2 diabetes: the E3N-EPIC cohort study. Diabetologia. 2014 Feb;57(2):313-20. doi: 10.1007/s00125-013-3100-0.

    PMID: 24232975BACKGROUND

  • Reaich D, Graham KA, Channon SM, Hetherington C, Scrimgeour CM, Wilkinson R, Goodship TH. Insulin-mediated changes in PD and glucose uptake after correction of acidosis in humans with CRF. Am J Physiol. 1995 Jan;268(1 Pt 1):E121-6. doi: 10.1152/ajpendo.1995.268.1.E121.

    PMID: 7840169BACKGROUND

  • Souto G, Donapetry C, Calvino J, Adeva MM. Metabolic acidosis-induced insulin resistance and cardiovascular risk. Metab Syndr Relat Disord. 2011 Aug;9(4):247-53. doi: 10.1089/met.2010.0108. Epub 2011 Feb 25.

    PMID: 21352078BACKGROUND

  • Adeva MM, Souto G. Diet-induced metabolic acidosis. Clin Nutr. 2011 Aug;30(4):416-21. doi: 10.1016/j.clnu.2011.03.008. Epub 2011 Apr 9.

    PMID: 21481501BACKGROUND

  • Samocha-Bonet D, Campbell LV, Mori TA, Croft KD, Greenfield JR, Turner N, Heilbronn LK. Overfeeding reduces insulin sensitivity and increases oxidative stress, without altering markers of mitochondrial content and function in humans. PLoS One. 2012;7(5):e36320. doi: 10.1371/journal.pone.0036320. Epub 2012 May 7.

    PMID: 22586466BACKGROUND

  • Farwell WR, Taylor EN. Serum bicarbonate, anion gap and insulin resistance in the National Health and Nutrition Examination Survey. Diabet Med. 2008 Jul;25(7):798-804. doi: 10.1111/j.1464-5491.2008.02471.x.

    PMID: 18644066BACKGROUND

  • Mandel EI, Curhan GC, Hu FB, Taylor EN. Plasma bicarbonate and risk of type 2 diabetes mellitus. CMAJ. 2012 Sep 18;184(13):E719-25. doi: 10.1503/cmaj.120438. Epub 2012 Jul 23.

    PMID: 22825995BACKGROUND

  • Crawford SO, Hoogeveen RC, Brancati FL, Astor BC, Ballantyne CM, Schmidt MI, Young JH. Association of blood lactate with type 2 diabetes: the Atherosclerosis Risk in Communities Carotid MRI Study. Int J Epidemiol. 2010 Dec;39(6):1647-55. doi: 10.1093/ije/dyq126. Epub 2010 Aug 25.

    PMID: 20797988BACKGROUND

  • Lovejoy J, Newby FD, Gebhart SS, DiGirolamo M. Insulin resistance in obesity is associated with elevated basal lactate levels and diminished lactate appearance following intravenous glucose and insulin. Metabolism. 1992 Jan;41(1):22-7. doi: 10.1016/0026-0495(92)90185-d.

    PMID: 1538640BACKGROUND

  • Hayata H, Miyazaki H, Niisato N, Yokoyama N, Marunaka Y. Lowered extracellular pH is involved in the pathogenesis of skeletal muscle insulin resistance. Biochem Biophys Res Commun. 2014 Feb 28;445(1):170-4. doi: 10.1016/j.bbrc.2014.01.162. Epub 2014 Feb 3.

    PMID: 24502946BACKGROUND

  • Akter S, Eguchi M, Kurotani K, Kochi T, Pham NM, Ito R, Kuwahara K, Tsuruoka H, Mizoue T, Kabe I, Nanri A. High dietary acid load is associated with increased prevalence of hypertension: the Furukawa Nutrition and Health Study. Nutrition. 2015 Feb;31(2):298-303. doi: 10.1016/j.nut.2014.07.007. Epub 2014 Jul 30.

    PMID: 25592007BACKGROUND

  • Juraschek SP, Selvin E, Miller ER, Brancati FL, Young JH. Plasma lactate and diabetes risk in 8045 participants of the atherosclerosis risk in communities study. Ann Epidemiol. 2013 Dec;23(12):791-796.e4. doi: 10.1016/j.annepidem.2013.09.005. Epub 2013 Oct 5.

    PMID: 24176820BACKGROUND

  • Heilbronn LK, Gan SK, Turner N, Campbell LV, Chisholm DJ. Markers of mitochondrial biogenesis and metabolism are lower in overweight and obese insulin-resistant subjects. J Clin Endocrinol Metab. 2007 Apr;92(4):1467-73. doi: 10.1210/jc.2006-2210. Epub 2007 Jan 23.

    PMID: 17244782BACKGROUND

  • Maalouf NM, Cameron MA, Moe OW, Adams-Huet B, Sakhaee K. Low urine pH: a novel feature of the metabolic syndrome. Clin J Am Soc Nephrol. 2007 Sep;2(5):883-8. doi: 10.2215/CJN.00670207. Epub 2007 Aug 16.

    PMID: 17702734BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sodium Bicarbonate

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BicarbonatesCarbonatesCarbonic AcidCarbon Compounds, InorganicInorganic ChemicalsSodium Compounds

Study Officials

  • Dorit Samocha-Bonet, BSc(Hons) MSc(Hons) PhD

    Garvan Institute of Medical Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Leader, Clinical Insulin Resistance Group, Diabetes and Metabolism Division

Study Record Dates

First Submitted

July 13, 2015

First Posted

July 17, 2015

Study Start

March 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

March 7, 2017

Record last verified: 2017-03

Locations

AU(1)