N/A
N=44
Effect of Fermentable Carbohydrate on Glucose Homeostasis
Prediabetes
Bottom Line
View on ClinicalTrials.gov: NCT01841073 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Glycaemic Control — -0.23; 0.44 mmol//l — p=0.005
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Inulin (Dietary_supplement); Cellulose (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Imperial College London
- Primary completion
- Aug 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Glycaemic Control |
-0.23; 0.44 | 0.005 sig |
| SECONDARY Food Intake in Gram at 9 Weeks |
-127; -0.47 | 0.027 sig |
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 fibre - fermentable carbohydrate - may help prevent diabetes in individuals with IGT by reducing appetite and food intake, and improving insulin sensitivity. Although fermentable carbohydrate is not absorbed in the small intestine it is full fermented by the colonic bacteria. The fermentation of this carbohydrate produces short chain fatty acids which act on specific G protein coupled receptors (GPR41/43) in the intestine to release GLP-1 and PYY. GLP-1 and PYY are hormones which act on appetite centres in the brain to decrease appetite. GLP-1 incretin effects and possible effect of the beta cell will increase insulin sensitivity. Short chain fatty acids also suppress the release of free fatty acids from adipocytes. Lower levels of free fatty acids in insulin resistant subject's leads to improved insulin sensitivity. This body of work will examine the effect of fermentable carbohydrate on appetite, weight loss, blood glucose control which will give an indication of the possibility of fermentable carbohydrate to prevent type 2 diabetes in this at-risk group.
Eligibility Criteria
Inclusion Criteria
- Investigation 1 and 3: An oral glucose tolerance test diagnostic of impaired glucose tolerance as defined by the WHO as a fasting plasma glucose 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01841073). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.