Diabetes MellitusNCT01692002
Oral Propionate to Treat and Prevent Diabetes
A study testing Sodium propionate, Sodium Chloride and Oral glucose tolerance test in people with Diabetes Mellitus, run by Imperial College London at 3 sites in United Kingdom.
Trial summary
The aim of these studies is to firstly determine the pharmacokinetic profile of orally administered enteric coated sodium propionate. Subsequently, the most efficacious dose at improving glucose tolerance following an oral glucose challenge will be determined. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Sodium propionate, Sodium Chloride and Oral glucose tolerance test
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Jan 2013to Aug 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Study 1: Healthy men and women aged between 18 and 70 years with BMI between 20-25 kg/m2 and with normal fasting blood glucose (below5.5mmol/l and HbA1C less than 5.7% will be eligible to volunteer.
- Study 2: As for Study 1. Study 3: Cohort 1: Volunteers aged between 30 to 70 with a BMI between 25-35 kg/m2 who do not have impaired fasting glucose and have HbA1c below 5.7%.
- Cohort 2: Volunteers aged between 30 to 70 years with a BMI between 25-35 kg/m2 who have impaired fasting glucose (between 5.5-7mmol/l) and HbA1C between 5.7% and 6.5%,
Who cannot join
- Gained or lost ≥ 3kg weight in the past three months
- Taken prescription medicines having an impact on metabolism, appetite regulation, glucose homeostasis and hormonal regulation
- Taken any dietary supplements in the last 6 months
- Any chronic illness
- Cardiovascular disease
- Excess alcohol intake
Show all 12Show fewer
- Current smokers
- Any gastrointestinal disorder e.g. Crohn's disease, coeliac disease or irritable bowel syndrome
- A history of drug or alcohol abuse in the last 2 years
- Pregnancy (all women of child bearing age will undergo a pregnancy test).
- Pancreatitis
- Use of medications likely to interfere with glucose metabolism, appetite regulation, hormonal balance.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Hammersmith Hospital
London, UK, W12 0NN
Imperial College London
London, W12 0NN
St John McMichael Centre - Imperial College London
London, W12 0NN
About this study
Official title: Development of Orally Administered Sodium Propionate to Treat and Prevent Diabetes
The aim of these studies is to firstly determine the pharmacokinetic profile of orally administered enteric coated sodium propionate. Subsequently, the most efficacious dose at improving glucose tolerance following an oral glucose challenge will be determined. The investigators will then determine the mechanism of action of propionate, whether it acts by altering beta cell function directly or by augmenting the incretin effect or both
Read the detailed description
The NHS spends £1M per hour, 10% of its yearly budget, treating diabetes. In the UK cases of diabetes are expected to top 4 million by 2025. There is an urgent need for new therapies. The short chain fatty acid propionate is a natural substance produced by digestion of fermentable carbohydrates. Preclinical and early human data demonstrate it improves pancreatic function and glucose control. The investigators aim to conduct proof of principle studies to determine if oral delivery of propionate improves glucose control in patients at risk of developing diabetes.
- Conditions
- Diabetes Mellitus
- Being tested
- Sodium propionate, Sodium Chloride, Oral glucose tolerance test, Intravenous glucose tolerance test.
- Keywords
- Diabetes Mellitus, Propionate
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium propionateDietary supplement
Sodium propionate capsule or tablet
Sodium ChlorideDietary supplement
Placebo capsule or tablet
Oral glucose tolerance testProcedure or surgery
Intravenous glucose tolerance test.Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Sodium chloride pill | Placebo comparator | Study 1: pharmacokinetics Study2: Oral glucose tolerance test Study 3: intravenous glucose tolerance test Receives: Dietary Supplement: Sodium Chloride; Procedure: Oral glucose tolerance test; Procedure: Intravenous glucose tolerance test. |
| Sodium propionate pill | Experimental | Study 1: pharmacokinetics Study2: Oral glucose tolerance test Study 3: intravenous glucose tolerance test Receives: Dietary Supplement: Sodium propionate; Procedure: Oral glucose tolerance test; Procedure: Intravenous glucose tolerance test. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Propionate CMax
Study 1: Peak plasma concentration of propionate. Dose ranging and pharmacokinetic profile of propionate by Mass spectrometry has been measured at -10, 0, 15, 30, 60, 90, 120, 150, 180, 4h, 6h, 8h (the mean below was estimated first per patient (across all the above time points) and then per arm across the 6 patients)
Measured: hours (up to 8hrs)
Secondary outcomes (3)
Total Amount of Insulin Stimulated by Propionate Per Unit Time (Incremental Area Under the Curve)
Study 3: Participants will undergo a frequently sampled oral glucose tolerance test (OGTT) to detect changes in insulin sensitivity and beta cell function. Where maximum insulin increments during a glucose tolerance test will be reported on a scale 0 to 1000 where 0 is the lowest and 1000 is the highest outcome
Measured: 10 minutes
Insulinogenic Index (Change in Insulin Divided by the Change in Glucose Over the First 30 Minutes of the Test)
Study 2: insulinogenic index. Oral glucose tolerance dose finding was measured with commercially available kits (the mean below was estimated per arm across the 6 patients)
Measured: 30mins
Insulin Levels in Response to the Absorption of Proprionate (Total Insulin Across All Time Points)
Plasma insulin has been measured using commercially available kits at -10, 0, 15, 30, 60, 90, 120, 150, 180, 4h, 6h, 8h (the mean below was estimated first per patient (across all the above time points) and then per arm across the 6 patients)
Measured: hours (up to 8 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2012 (estimated)
- Study startJan 2013
- Primary completionAug 2019
- Study completionAug 2019
Why it stopped: The person who was running the study never completed it, as the study never reached the target recruitment levels.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- Model description
- the study was terminated so data were referred to only 6 people despite a target recruitment of 12
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gavin A Bewick, PhD., Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01692002
- Sponsor's protocol ID
- CRO2020
- Status last verified
- Jun 2025
- First submitted
- 11 Sep 2012
- Last updated
- 18 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Orally Administered Sodium Propionate to Treat and Prevent Diabetes
- ClinicalTrials.gov ID
- NCT01692002
- Acronym / sponsor ID
- CRO2020
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes Mellitus, Propionate
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The person who was running the study never completed it, as the study never reached the target recruitment levels.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Aug 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 25 Sep 2012 (estimated)
- Results
- Posted 18 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of these studies is to firstly determine the pharmacokinetic profile of orally administered enteric coated sodium propionate. Subsequently, the most efficacious dose at improving glucose tolerance following an oral glucose challenge will be determined. The investigators will then determine the mechanism of action of propionate, whether it acts by altering beta cell function directly or by augmenting the incretin effect or both
Detailed description
The NHS spends £1M per hour, 10% of its yearly budget, treating diabetes. In the UK cases of diabetes are expected to top 4 million by 2025. There is an urgent need for new therapies. The short chain fatty acid propionate is a natural substance produced by digestion of fermentable carbohydrates. Preclinical and early human data demonstrate it improves pancreatic function and glucose control. The investigators aim to conduct proof of principle studies to determine if oral delivery of propionate improves glucose control in patients at risk of developing diabetes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- the study was terminated so data were referred to only 6 people despite a target recruitment of 12
| Arm | Type | Receives |
|---|---|---|
| Sodium chloride pill | Placebo comparator | Dietary Supplement: Sodium Chloride, Procedure: Oral glucose tolerance test, Procedure: Intravenous glucose tolerance test.Study 1: pharmacokinetics Study2: Oral glucose tolerance test Study 3: intravenous glucose tolerance test |
| Sodium propionate pill | Experimental | Dietary Supplement: Sodium propionate, Procedure: Oral glucose tolerance test, Procedure: Intravenous glucose tolerance test.Study 1: pharmacokinetics Study2: Oral glucose tolerance test Study 3: intravenous glucose tolerance test |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Study 1: Healthy men and women aged between 18 and 70 years with BMI between 20-25 kg/m2 and with normal fasting blood glucose (below5.5mmol/l and HbA1C less than 5.7% will be eligible to volunteer.
- Study 2: As for Study 1. Study 3: Cohort 1: Volunteers aged between 30 to 70 with a BMI between 25-35 kg/m2 who do not have impaired fasting glucose and have HbA1c below 5.7%.
- Cohort 2: Volunteers aged between 30 to 70 years with a BMI between 25-35 kg/m2 who have impaired fasting glucose (between 5.5-7mmol/l) and HbA1C between 5.7% and 6.5%,
Key exclusion criteria (12 listed)
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 propionateSodium propionate capsule or tablet | Dietary supplement | Sodium propionate pill |
| Sodium ChloridePlacebo capsule or tablet | Dietary supplement | Sodium chloride pill |
| Oral glucose tolerance test | Procedure or surgery | Sodium chloride pill, Sodium propionate pill |
| Intravenous glucose tolerance test. | Procedure or surgery | Sodium chloride pill, Sodium propionate pill |
Primary outcome
Propionate CMax
Time frame: hours (up to 8hrs)
Study 1: Peak plasma concentration of propionate. Dose ranging and pharmacokinetic profile of propionate by Mass spectrometry has been measured at -10, 0, 15, 30, 60, 90, 120, 150, 180, 4h, 6h, 8h (the mean below was estimated first per patient (across all the above time points) and then per arm across the 6 patients)
3 secondary outcomes
Total Amount of Insulin Stimulated by Propionate Per Unit Time (Incremental Area Under the Curve)
Time frame: 10 minutes
Insulinogenic Index (Change in Insulin Divided by the Change in Glucose Over the First 30 Minutes of the Test)
Time frame: 30mins
Insulin Levels in Response to the Absorption of Proprionate (Total Insulin Across All Time Points)
Time frame: hours (up to 8 hours)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Gavin A Bewick, PhD. principal investigator
Imperial College London
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium propionate, Sodium Chloride and Oral glucose tolerance test in people with Diabetes Mellitus, run by Imperial College London at 3 sites in United Kingdom.
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 3 inclusion and 12 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: stopped early, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. 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?
Yes. Results are posted in the registry (first posted 18 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Propionate CMax (time frame: hours (up to 8hrs)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2025.