Oral Propionate to Treat and Prevent Diabetes

NCT ID: NCT01692002

Last Updated: 2025-06-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2019-08-31

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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Sodium chloride pill

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

Group Type: PLACEBO_COMPARATOR

Sodium Chloride

Intervention Type: DIETARY_SUPPLEMENT

Placebo capsule or tablet

Oral glucose tolerance test

Intervention Type: PROCEDURE

Intravenous glucose tolerance test.

Intervention Type: PROCEDURE

Sodium propionate pill

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

Group Type: EXPERIMENTAL

Sodium propionate

Intervention Type: DIETARY_SUPPLEMENT

Sodium propionate capsule or tablet

Oral glucose tolerance test

Intervention Type: PROCEDURE

Intravenous glucose tolerance test.

Intervention Type: PROCEDURE

Interventions

Sodium propionate

Sodium propionate capsule or tablet

Intervention Type: DIETARY_SUPPLEMENT

Sodium Chloride

Placebo capsule or tablet

Intervention Type: DIETARY_SUPPLEMENT

Oral glucose tolerance test

Intervention Type: PROCEDURE

Intravenous glucose tolerance test.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Imperial College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gavin A Bewick, PhD.

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

Hammersmith Hospital

London, UK, United Kingdom

Imperial College London

London, , United Kingdom

St John McMichael Centre - Imperial College London

London, , United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CRO2020

Identifier Type: -

Identifier Source: org_study_id