Oral Propionate to Treat and Prevent Diabetes

Imperial College London

Status: Terminated

Conditions: Diabetes Mellitus

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01692002

CRO2020

Details and patient eligibility

About

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

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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:• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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6 participants in 2 patient groups, including a placebo group

Sodium chloride pill

Placebo Comparator group

Description:

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

Treatment:

Procedure: Oral glucose tolerance test

Dietary Supplement: Sodium Chloride

Procedure: Intravenous glucose tolerance test.

Sodium propionate pill

Experimental group

Description:

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

Treatment:

Procedure: Oral glucose tolerance test

Dietary Supplement: Sodium propionate

Procedure: Intravenous glucose tolerance test.