Oral Propionate to Treat and Prevent Diabetes | Completed
Oral Propionate to Treat and Preven... | Completed
Oral Propionate to Treat and Prevent Diabetes

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Medical Conditions
  • Diabetes Mellitus
Primary Contact Details
Unfortunately contact details are not available for this trial.
Recruitment Status
Completed
Trial source and source ID number
NCT01692002

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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
Research Details
  • 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.
Phase
Phase 2
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Dietary Supplement : Sodium propionate, Dietary Supplement : Sodium Chloride, Procedure : Oral glucose tolerance test, Procedure : Intravenous glucose tolerance test.

Study Arm Groups : Sodium propionate pill, Sodium chloride pill, Sodium chloride pill, Sodium propionate pill, Sodium chloride pill, Sodium propionate pill

Intervention Type
See Interventions above
Primary Outcome Measures
    Study 1: Peak plasma concentration of propionate; at -10, 0, 15, 30, 60, 90, 120, 150, 180, 4h, 6h, 8h; Study 2: insulinogenic index; 0-30mins; Study 3: Incremental area under the insulin profile; 0-10mins
Secondary Outcome Measures
    Insulin; -10, 0, 15, 30, 60, 90, 120, 150, 180, 4h, 6h, 8h
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
18 Years - 70 Years
Who Can Participate
Sorry, this information is not available
Number of Participants
Sorry, this information is not available
Participant Inclusion 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.
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
London
W12 0NN
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
Development of Orally Administered Sodium Propionate to Treat and Prevent Diabetes
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
CRO2020 - Imperial College Lon
Sponsor(s)
Imperial College London
Key Dates

Recruitment Start Date

Jan 2013

Recruitment End Date

Apr 2016

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

11 Sep 2012

Date updated in source

18 Nov 2016