Oral Propionate to Treat and Prevent Diabetes

Diabetes Mellitus Clinical Trial

Official title:

Development of Orally Administered Sodium Propionate to Treat and Prevent Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01692002
• Other study ID #: CRO2020
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: August 2019

Study information

• Verified date: October 2019
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

• 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.

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Dietary Supplement:
• Sodium propionate
Sodium propionate capsule or tablet
• Sodium Chloride
Placebo capsule or tablet

Procedure:
• Oral glucose tolerance test

• Intravenous glucose tolerance test.

Locations

Country	Name	City	State
United Kingdom	Hammersmith Hospital	London	UK
United Kingdom	Imperial College London	London
United Kingdom	St John McMichael Centre - Imperial College London	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study 1: Peak plasma concentration of propionate	Dose ranging and pharmacokinetic profile	at -10, 0, 15, 30, 60, 90, 120, 150, 180, 4h, 6h, 8h
Primary	Study 2: insulinogenic index	oral glucose tolerance dose finding	0-30mins
Primary	Study 3: Incremental area under the insulin profile	Intravenous glucose tolerance test	0-10mins
Secondary	Insulin	Plasma insulin	-10, 0, 15, 30, 60, 90, 120, 150, 180, 4h, 6h, 8h