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The person who was running the study never completed it, as the study never reached the target recruitment levels.
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sodium chloride pill | Placebo Comparator | Study 1: pharmacokinetics Study2: Oral glucose tolerance test Study 3: intravenous glucose tolerance test |
|
| Sodium propionate pill | Experimental | Study 1: pharmacokinetics Study2: Oral glucose tolerance test Study 3: intravenous glucose tolerance test |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium propionate | Dietary Supplement | Sodium propionate capsule or tablet |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | hours (up to 8hrs) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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%,
Exclusion Criteria:• Type 1 or Type 2 Diabetes
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| Name | Affiliation | Role |
|---|---|---|
| Gavin A Bewick, PhD. | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hammersmith Hospital | London | UK | W12 0NN | United Kingdom | ||
| Imperial College London |
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Wash out of 7 days between interventions
Recruitment started March 2013 and ended August 2016. The study was based at the clinical research facility at Imperial College Health Care Trust but never completed. Only 6 where recriuted and completed. The target was 12
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| ID | Title | Description |
|---|---|---|
| FG000 | Sodium Chloride Pill | Study 1: pharmacokinetics Study2: Oral glucose tolerance test Study 3: intravenous glucose tolerance test Sodium Chloride: Placebo capsule or tablet Oral glucose tolerance test Intravenous glucose tolerance test. |
| FG001 | Sodium Propionate Pill | Study 1: pharmacokinetics Study2: Oral glucose tolerance test Study 3: intravenous glucose tolerance test Sodium propionate: Sodium propionate capsule or tablet Oral glucose tolerance test Intravenous glucose tolerance test. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1st Period of the Cross-over Study |
| |||||||||||||
| Washout Period |
| |||||||||||||
| 2nd Period of the Cross-over Study |
|
only 6 where recriuted and completed
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| ID | Title | Description |
|---|---|---|
| BG000 | Sodium Chloride | Sodium Chloride Pill Intervention |
| BG001 | Sodium Propionate | Sodium propionate pill |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 3 dropped out |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Propionate concertation in plasma | Posted | Mean | Standard Deviation | mmol/l | hours (up to 8hrs) |
|
1 week
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sodium Chloride Pill | Study 1: pharmacokinetics Study2: Oral glucose tolerance test Study 3: intravenous glucose tolerance test Sodium Chloride: Placebo capsule or tablet Oral glucose tolerance test Intravenous glucose tolerance test. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof Gary Frost Head of Section for Nutrition Research | Imperial College London | 07872850308 | g.frost9296@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 1, 2012 | Nov 28, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C514135 | sodium propionate |
| D012965 | Sodium Chloride |
| D005951 | Glucose Tolerance Test |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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the study was terminated so data were referred to only 6 people despite a target recruitment of 12
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| Sodium Chloride |
| Dietary Supplement |
Placebo capsule or tablet |
|
| Oral glucose tolerance test | Procedure |
|
| Intravenous glucose tolerance test. | Procedure |
|
| 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) | 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) | hours (up to 8 hours) |
| London |
| W12 0NN |
| United Kingdom |
| St John McMichael Centre - Imperial College London | London | W12 0NN | United Kingdom |
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | 3 dropped out | Count of Participants | Participants |
|
| Race (NIH/OMB) | 3 dropped out | Count of Participants | Participants |
|
| Region of Enrollment | 3 dropped out | Count of Participants | Participants |
|
| Propionate | 3 dropped out | Mean | Standard Deviation | micromol/l |
|
Study 1: pharmacokinetics Study2: Oral glucose tolerance test Study 3: intravenous glucose tolerance test Sodium propionate: Sodium propionate capsule or tablet Oral glucose tolerance test Intravenous glucose tolerance test. |
|
|
| Secondary | 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 | Posted | Mean | Standard Error | uM/min | 10 minutes |
|
|
|
| Secondary | 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) | This index is estimated on a scale 0 to 50 where 0 is the lowest value and 50 is the highest value | Posted | Mean | Standard Deviation | index | 30mins |
|
|
|
| Secondary | 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) | The mean below was estimated first per patient (across all the above time points) and then per arm across the 6 patients. | Posted | Mean | 95% Confidence Interval | uM/l | hours (up to 8 hours) |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | Sodium Propionate Pill | Study 1: pharmacokinetics Study2: Oral glucose tolerance test Study 3: intravenous glucose tolerance test Sodium propionate: Sodium propionate capsule or tablet Oral glucose tolerance test Intravenous glucose tolerance test. | 0 | 3 | 0 | 3 | 0 | 3 |
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| D017670 |
| Sodium Compounds |
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008919 | Investigative Techniques |