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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
History of Changes
  Purpose

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


Condition Intervention Phase
Diabetes.
 Dietary Supplement: Sodium propionate
Dietary Supplement: Sodium Chloride
Procedure: Oral glucose tolerance test
Procedure: Intravenous glucose tolerance test.
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Development of Orally Administered Sodium Propionate to Treat and Prevent Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Insulin [ Time Frame: -10, 0, 15, 30, 60, 90, 120, 150, 180, 4h, 6h, 8h ] [ Designated as safety issue: No ]
    Plasma insulin


Estimated Enrollment: 104
Study Start Date: January 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Sodium chloride pill
Study 1: pharmacokinetics Study2: Oral glucose tolerance test Study 3: intravenous glucose tolerance test
 Dietary Supplement: Sodium Chloride
Placebo capsule or tablet
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
 Dietary Supplement: Sodium propionate
Sodium propionate capsule or tablet
Procedure: Oral glucose tolerance test Procedure: Intravenous glucose tolerance test.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01692002

Contacts
Contact: Gavin A Bewick, PhD 02083833086 g.bewick@imperial.ac.uk
Contact: Gary Frost, PhD g.frost@imeprial.ac.uk

Locations
United Kingdom
St John McMichael Centre - Imperial College London Not yet recruiting
London, United Kingdom, W12 0NN
Principal Investigator: Gavin A Bewick, PhD            
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: Gavin A Bewick, PhD. Imperial College London
  More Information

No publications provided

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01692002     History of Changes
Other Study ID Numbers: CRO2020 - Imperial College Lon
Study First Received: September 11, 2012
Last Updated: September 20, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 18, 2013