Oral Propionate to Treat and Prevent Diabetes

This study is not yet open for participant recruitment.
Verified September 2012 by Imperial College London
Sponsor:
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01692002
First received: September 11, 2012
Last updated: September 20, 2012
Last verified: September 2012

September 11, 2012
September 20, 2012
January 2013
December 2016   (final data collection date for primary outcome measure)
  • Study 1: Peak plasma concentration of propionate [ Time Frame: at -10, 0, 15, 30, 60, 90, 120, 150, 180, 4h, 6h, 8h ] [ Designated as safety issue: No ]
    Dose ranging and pharmacokinetic profile
  • Study 2: insulinogenic index [ Time Frame: 0-30mins ] [ Designated as safety issue: No ]
    oral glucose tolerance dose finding
  • Study 3: Incremental area under the insulin profile [ Time Frame: 0-10mins ] [ Designated as safety issue: No ]
    Intravenous glucose tolerance test
Same as current
Complete list of historical versions of study NCT01692002 on ClinicalTrials.gov Archive Site
Insulin [ Time Frame: -10, 0, 15, 30, 60, 90, 120, 150, 180, 4h, 6h, 8h ] [ Designated as safety issue: No ]
Plasma insulin
Same as current
Not Provided
Not Provided
 
Oral Propionate to Treat and Prevent Diabetes
Development of Orally Administered Sodium Propionate to Treat and Prevent Diabetes

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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Diabetes.
  • Dietary Supplement: Sodium propionate
    Sodium propionate capsule or tablet
  • Dietary Supplement: Sodium Chloride
    Placebo capsule or tablet
  • Procedure: Oral glucose tolerance test
  • Procedure: Intravenous glucose tolerance test.
  • Placebo Comparator: Sodium chloride pill
    Study 1: pharmacokinetics Study2: Oral glucose tolerance test Study 3: intravenous glucose tolerance test
    Interventions:
    • Dietary Supplement: Sodium Chloride
    • Procedure: Oral glucose tolerance test
    • Procedure: Intravenous glucose tolerance test.
  • Experimental: Sodium propionate pill
    Study 1: pharmacokinetics Study2: Oral glucose tolerance test Study 3: intravenous glucose tolerance test
    Interventions:
    • Dietary Supplement: Sodium propionate
    • Procedure: Oral glucose tolerance test
    • Procedure: Intravenous glucose tolerance test.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
104
December 2016
December 2016   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
Yes
Contact: Gavin A Bewick, PhD 02083833086 g.bewick@imperial.ac.uk
Contact: Gary Frost, PhD g.frost@imeprial.ac.uk
United Kingdom
 
NCT01692002
CRO2020 - Imperial College Lon
Yes
Imperial College London
Imperial College London
Not Provided
Principal Investigator: Gavin A Bewick, PhD. Imperial College London
Imperial College London
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP