Specialty: Diabetes, Primary sub-specialty: Other Nutritional, Metabolic, Endocrine Diabetes
Conditions
Interventions
All participants attend a health screening which includes an oral glucose tolerance test. The health screening should last about 2.5 hours. All participants will attend a 2.5 hour baseline study day t
Sponsors
Imperial College London and Imperial College Healthcare NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults over 18 years of age 2. Isolated impaired fasting glucose (fasting plasma glucose of 6.16.9mmol/L and 2 hour plasma glucose following 75g glucose of 7.8mmol/L < 11.1 mmol/L) 3. BMI between 25-35 kg/m2 4. The volunteers should have given full written consent. 5. Have had a stable body weight for the last 3 months (< 5% change)
Exclusion criteria
Exclusion criteria: 1. Pregnant and lactating women 2. Volunteers unable to give informed consent for themselves 3. Volunteers with a major metabolic disease – including diabetes 4. Has a known/diagnosed gastrointestinal problems inflammatory bowel disease, irritable bowel syndrome etc. 5. Failure of the medical examination for inclusion into the study 6. Those with anaemia (Hb <10g/l) 7. Drug or alcohol abuse in the last 2 years 8. Regular ingestion of specifically labelled prebiotic or probiotic functional foods for two weeks before commencement of the study and then for the duration of the intervention
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fasting blood glucose is measured using a venous blood sample taken following a 10-hour fast at baseline and 6 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. HOMA-IR is measured using fasting glucose and insulin samples from: https://www.dtu.ox.ac.uk/homacalculator/ at baseline and 6 weeks 2. Fasting insulin is measured using a venous blood sample taken following a 10-hour fast at baseline and 6 weeks 3. Insulin secretion as measured by Insulin Secretion Index (ISI) calculated as the ratio of total AUC insulin to total AUC glucose taken from the meal tolerance test, with blood samples collected at 5, 15, 20, 30, 60, 90 and 120 minutes at baseline and 6 weeks 4. tAUC glucose calculated using the trapezoid measure taken from venous glucose samples collected at 0, 5, 15, 20, 30, 60, 90 and 120 minutes at baseline and 6 weeks 5. tAUC insulin calculated using the trapezoid measure taken from venous insulin samples collected at 0, 5, 15, 20, 30, 60, 90 and 120 minutes at baseline and 6 weeks 6. Body weight measured to one decimal point in light clothes and shoes removed at baseline and 6 weeks | — |
Countries
England, United Kingdom
Contacts
Public ContactNicola Guess
Outcome results
None listed