Oral Propionate to Treat and Prevent Diabetes

NCT01692002 | Terminated Results DMC

• 1 other identifier: CRO2020
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 3

Brief 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. 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

Conditions

Diabetes Mellitus

Keywords

Diabetes Mellitus; Propionate

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (3)

• Total Amount of Insulin Stimulated by Propionate Per Unit Time (Incremental Area Under the Curve)

  10 minutes

• Insulinogenic Index (Change in Insulin Divided by the Change in Glucose Over the First 30 Minutes of the Test)

  30mins

• Insulin Levels in Response to the Absorption of Proprionate (Total Insulin Across All Time Points)

  hours (up to 8 hours)

Study Arms (2)

Sodium chloride pill

PLACEBO COMPARATOR

Study 1: pharmacokinetics Study2: Oral glucose tolerance test Study 3: intravenous glucose tolerance test

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

Dietary Supplement: Sodium propionate; Procedure: Oral glucose tolerance test; Procedure: Intravenous glucose tolerance test.

Interventions

Sodium propionate DIETARY_SUPPLEMENT

Sodium propionate capsule or tablet

Sodium propionate pill

Sodium Chloride DIETARY_SUPPLEMENT

Placebo capsule or tablet

Sodium chloride pill

Oral glucose tolerance test PROCEDURE

Sodium chloride pill; Sodium propionate pill

Intravenous glucose tolerance test. PROCEDURE

Sodium chloride pill; Sodium propionate pill

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%,

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (3)

Hammersmith Hospital

London, UK, W12 0NN, United Kingdom

Location

Imperial College London

London, W12 0NN, United Kingdom

Location

St John McMichael Centre - Imperial College London

London, W12 0NN, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

sodium propionate; Sodium Chloride; Glucose Tolerance Test

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques

Results Point of Contact

• Title: Prof Gary Frost Head of Section for Nutrition Research
• Organization: Imperial College London

g.frost9296@gmail.com

07872850308

Study Officials

• Gavin A Bewick, PhD.

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: the study was terminated so data were referred to only 6 people despite a target recruitment of 12

Study Record Dates

• First Submitted: September 11, 2012
• First Posted: September 25, 2012
• Study Start: January 1, 2013
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: June 18, 2025
• Results First Posted: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)