DysglycemiaADISNCT02501343
Alkaline Diet for Insulin Sensitivity
A study testing Sodium Bicarbonate Oral Capsule in people with Dysglycemia and Type 2 Diabetes Mellitus, run by Garvan Institute of Medical Research at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dysglycemia, Type 2 Diabetes Mellitus
- What is being tested?
- Sodium Bicarbonate Oral Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteAustralia
- Study dates
- Mar 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Garvan Institute of Medical Research
Darlinghurst, New South Wales, 2010
About this study
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.
Read the 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.
- Conditions
- Dysglycemia, Type 2 Diabetes Mellitus
- Being tested
- Sodium Bicarbonate Oral Capsule, Placebo
- Keywords
- Glucose metabolism, Potential renal acid load, Postprandial glycemia, Body acid-base homeostasis, Sodium bicarbonate
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Bicarbonate Oral CapsuleDrug
Also called Sodibic capsules (Aspen Australia, NSW, Australia)
Sodium bicarbonate 1680 mg will be administered prior to the meal
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
| Study group | Role | What they receive |
|---|---|---|
| Sodium bicarbonate | Experimental | High acid load meal (Western style meal) with Sodium bicarbonate (Sodibic 840mg*2) Receives: Drug: Sodium Bicarbonate Oral Capsule |
| Placebo | Placebo comparator | High acid load meal (Western style meal) with sodibic-matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline (fasting) and 3 hours post meal
Secondary outcomes (4)
Changes in glycemic response to the meal
Postprandial glucose excursion will be compared between sodium bicarbonate and placebo
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline (fasting) and 3 hours post meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for DysglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Garvan Institute of Medical Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dorit Samocha-Bonet, Garvan Institute of Medical Research
- Investigators
- Dorit Samocha-Bonet, BSc(Hons) MSc(Hons) PhD, Principal investigator, Garvan Institute of Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02501343
- Sponsor's protocol ID
- ADIS (SVH 14/157)
- Acronym
- ADIS
- Status last verified
- Mar 2017
- First submitted
- 13 Jul 2015
- Last updated
- 7 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 434194Fagherazzi 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.
PubMed 24232975Reaich 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.
PubMed 7840169Souto 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.
PubMed 21352078Adeva 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.
PubMed 21481501Samocha-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.
PubMed 22586466Farwell 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.
PubMed 18644066Mandel 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.
PubMed 22825995Crawford 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.
PubMed 20797988Lovejoy 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.
PubMed 1538640Hayata 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.
PubMed 24502946Akter 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.
PubMed 25592007Juraschek 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.
PubMed 24176820Heilbronn 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.
PubMed 17244782Maalouf 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.
PubMed 17702734
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alkaline Diet for Insulin Sensitivity
- ClinicalTrials.gov ID
- NCT02501343
- Acronym / sponsor ID
- ADIS / ADIS (SVH 14/157)
- Conditions
- Dysglycemia, Type 2 Diabetes Mellitus
- Keywords
- Glucose metabolism, Potential renal acid load, Postprandial glycemia, Body acid-base homeostasis, Sodium bicarbonate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Garvan Institute of Medical ResearchUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 17 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium bicarbonate | Experimental | Drug: Sodium Bicarbonate Oral CapsuleHigh acid load meal (Western style meal) with Sodium bicarbonate (Sodibic 840mg*2) |
| Placebo | Placebo comparator | Drug: PlaceboHigh acid load meal (Western style meal) with sodibic-matching placebo |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium Bicarbonate Oral CapsuleAlso: Sodibic capsules (Aspen Australia, NSW, Australia)Sodium bicarbonate 1680 mg will be administered prior to the meal | Drug | Sodium bicarbonate |
| PlaceboSodibic-matching placebo (Stenlake Compounding Chemist, NSW, Australia) will be administered prior to the meal on a different day 1 to 2 weeks apart | Drug | Placebo |
Primary outcome
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
4 secondary outcomes
Changes in glycemic response to the meal
Time frame: Baseline (fasting) and 3 hours post meal
Changes in insulin response to the meal
Time frame: Baseline (fasting) and 3 hours post meal
Changes in arterial stiffness
Time frame: Baseline (fasting) and 3 hours post meal
Changes in hunger and satiety scores
Time frame: Baseline (fasting) and 3 hours post meal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2017.
- Background: PubMed 434194DeFronzo 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.
- Background: PubMed 24232975Fagherazzi 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.
- Background: PubMed 7840169Reaich 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.
- Background: PubMed 21352078Souto 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.
- Background: PubMed 21481501Adeva 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.
- Background: PubMed 22586466Samocha-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.
- Background: PubMed 18644066Farwell 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.
- Background: PubMed 22825995Mandel 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.
- Background: PubMed 20797988Crawford 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.
- Background: PubMed 1538640Lovejoy 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.
- Background: PubMed 24502946Hayata 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.
- Background: PubMed 25592007Akter 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dorit Samocha-Bonet, BSc(Hons) MSc(Hons) PhD principal investigator
Garvan Institute of Medical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium Bicarbonate Oral Capsule in people with Dysglycemia and Type 2 Diabetes Mellitus, run by Garvan Institute of Medical Research at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in venous blood pH (time frame: Baseline (fasting) and 3 hours post meal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02501343, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2017.