Status:
COMPLETED
Effect of Fermentable Carbohydrate on Glucose Homeostasis
Lead Sponsor:
Imperial College London
Conditions:
Prediabetes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The rise in the prevalence of type 2 diabetes is related to recent lifestyle changes leading to a rise in obesity. Obesity is a risk factor for Impaired Glucose Tolerance (IGT) and diabetes. A type of...
Detailed Description
TITLE The Effect of Fermentable Carbohydrate on Weight Management and Glycaemic Control in People at High Risk of Developing DMT2 AIMS To assess the effect of fermentable carbohydrate in subjects wit...
Eligibility Criteria
Inclusion
- Investigation 1 and 3: An oral glucose tolerance test diagnostic of impaired glucose tolerance as defined by the WHO as a fasting plasma glucose\<7.0mmol/l and a 2-h plasma glucose ≥7.8 and \<11.1mmol/l and/or impaired fasting glucose, defined by the American Diabetes Association as a fasting plasma glucose of \>5.6 and \<6.9mmol/L.
- Investigation 2: An oral glucose tolerance test diagnostic of impaired glucose tolerance as defined by the WHO as a fasting plasma glucose\<7.0mmol/l and a 2-h plasma glucose ≥7.8 and \<11.1mmol/l. For investigation 2, people with only IFG will be excluded.
- All investigations:
- Adults over 18 years of age
- Males and Females with a BMI between 25-35 kg/m2. The BMI range of between 25-35Kg/m2 has been chosen as this is the range that the majority of overweight people fall into (1). At this level of overweight and obesity there is an increase in the risk of type 2 diabetes. Above 40 kg/m2 there appears to be decreased success with lifestyle advice.
- The volunteers should have given full written consent.
- Have had a stable body weight for the last 6 months with no more than a 5% change in body weight over 6 months.
Exclusion
- Adults less than 18 years of age.
- Volunteers with a major metabolic disease - including diabetes.
- A normal oral glucose tolerance test or that diagnostic of diabetes by the WHO criteria.
- Pregnant and lactating women.
- Males and Females with a BMI less than 25kg/m2 or greater than 35kg/m2
- Volunteers unable to give informed consent for themselves.
- Has lost or gained 5% of their normal body weight in the last 6 months.
- Has a known/diagnosed gastrointestinal problem such as inflammatory bowel disease, irritable bowel syndrome etc
- Failure of the medical examination for inclusion into the study
- Those with anaemia (Hb \<10g/l)
- Drug or alcohol abuse in the last 2 years.
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01841073
Start Date
March 1 2011
End Date
August 1 2014
Last Update
November 25 2019
Active Locations (1)
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1
Imperial College London
London, United Kingdom, W11 0NN