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Trial Outcomes & Findings for Oral Propionate to Treat and Prevent Diabetes (NCT NCT01692002)

NCT ID: NCT01692002

Last Updated: 2025-06-18

Results Overview

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)

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

6 participants

Primary outcome timeframe

hours (up to 8hrs)

Results posted on

2025-06-18

Participant Flow

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

Wash out of 7 days between interventions

Participant milestones

Participant milestones
Measure
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.
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.
1st Period of the Cross-over Study
STARTED
3
3
1st Period of the Cross-over Study
COMPLETED
3
3
1st Period of the Cross-over Study
NOT COMPLETED
0
0
Washout Period
STARTED
3
3
Washout Period
COMPLETED
3
3
Washout Period
NOT COMPLETED
0
0
2nd Period of the Cross-over Study
STARTED
3
3
2nd Period of the Cross-over Study
COMPLETED
3
3
2nd Period of the Cross-over Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

3 dropped out

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Sodium Chloride
n=3 Participants
Sodium Chloride Pill Intervention
Sodium Propionate
n=3 Participants
Sodium propionate pill
Total
n=6 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants • 3 dropped out
0 Participants
n=7 Participants • 3 dropped out
0 Participants
n=5 Participants • 3 dropped out
Age, Categorical
Between 18 and 65 years
3 Participants
n=5 Participants • 3 dropped out
3 Participants
n=7 Participants • 3 dropped out
6 Participants
n=5 Participants • 3 dropped out
Age, Categorical
>=65 years
0 Participants
n=5 Participants • 3 dropped out
0 Participants
n=7 Participants • 3 dropped out
0 Participants
n=5 Participants • 3 dropped out
Sex: Female, Male
Female
2 Participants
n=5 Participants • 3 dropped out
2 Participants
n=7 Participants • 3 dropped out
4 Participants
n=5 Participants • 3 dropped out
Sex: Female, Male
Male
1 Participants
n=5 Participants • 3 dropped out
1 Participants
n=7 Participants • 3 dropped out
2 Participants
n=5 Participants • 3 dropped out
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants • 3 dropped out
0 Participants
n=7 Participants • 3 dropped out
0 Participants
n=5 Participants • 3 dropped out
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants • 3 dropped out
0 Participants
n=7 Participants • 3 dropped out
0 Participants
n=5 Participants • 3 dropped out
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants • 3 dropped out
0 Participants
n=7 Participants • 3 dropped out
0 Participants
n=5 Participants • 3 dropped out
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants • 3 dropped out
0 Participants
n=7 Participants • 3 dropped out
0 Participants
n=5 Participants • 3 dropped out
Race (NIH/OMB)
White
3 Participants
n=5 Participants • 3 dropped out
3 Participants
n=7 Participants • 3 dropped out
6 Participants
n=5 Participants • 3 dropped out
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants • 3 dropped out
0 Participants
n=7 Participants • 3 dropped out
0 Participants
n=5 Participants • 3 dropped out
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants • 3 dropped out
0 Participants
n=7 Participants • 3 dropped out
0 Participants
n=5 Participants • 3 dropped out
Region of Enrollment
United Kingdom
3 Participants
n=5 Participants • 3 dropped out
3 Participants
n=7 Participants • 3 dropped out
6 Participants
n=5 Participants • 3 dropped out
Propionate
0.05 micromol/l
STANDARD_DEVIATION 0.05 • n=5 Participants • 3 dropped out
0.05 micromol/l
STANDARD_DEVIATION 0.05 • n=7 Participants • 3 dropped out
0.05 micromol/l
STANDARD_DEVIATION 0.05 • n=5 Participants • 3 dropped out

PRIMARY outcome

Timeframe: hours (up to 8hrs)

Population: Propionate concertation in plasma

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)

Outcome measures

Outcome measures
Measure
Sodium Chloride Capsule
n=3 Participants
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.
Sodium Propionate Capsule
n=3 Participants
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.
Propionate CMax
7.2 mmol/l
Standard Deviation 0.26
7.79 mmol/l
Standard Deviation 0.25

SECONDARY outcome

Timeframe: 10 minutes

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

Outcome measures

Outcome measures
Measure
Sodium Chloride Capsule
n=3 Participants
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.
Sodium Propionate Capsule
n=3 Participants
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.
Total Amount of Insulin Stimulated by Propionate Per Unit Time (Incremental Area Under the Curve)
677.5 uM/min
Standard Error 24
678 uM/min
Standard Error 25

SECONDARY outcome

Timeframe: 30mins

Population: This index is estimated on a scale 0 to 50 where 0 is the lowest value and 50 is the highest value

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)

Outcome measures

Outcome measures
Measure
Sodium Chloride Capsule
n=3 Participants
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.
Sodium Propionate Capsule
n=3 Participants
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.
Insulinogenic Index (Change in Insulin Divided by the Change in Glucose Over the First 30 Minutes of the Test)
30.2 index
Standard Deviation 12
31 index
Standard Deviation 12.5

SECONDARY outcome

Timeframe: hours (up to 8 hours)

Population: The mean below was estimated first per patient (across all the above time points) and then per arm across the 6 patients.

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)

Outcome measures

Outcome measures
Measure
Sodium Chloride Capsule
n=3 Participants
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.
Sodium Propionate Capsule
n=3 Participants
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.
Insulin Levels in Response to the Absorption of Proprionate (Total Insulin Across All Time Points)
8142 uM/l
Interval 6809.0 to 9737.0
8316 uM/l
Interval 7148.0 to 9674.0

Adverse Events

Sodium Chloride Pill

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Sodium Propionate Pill

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof Gary Frost Head of Section for Nutrition Research

Imperial College London

Phone: 07872850308

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place