Phase
Condition
Diabetes Mellitus, Type 2
Diabetes Prevention
Diabetes And Hypertension
Treatment
N/AClinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Diagnosed with Type 2 Diabetes Mellitus without insulin treatment.
South Asian (Afghanistan, Bangladesh, Bhutan, Maldives, Nepal, India, Pakistan and SriLanka) or Caucasian Ancestry.
Age 18-70
5.5% ≤ HbA1c ≤ 9.0%
BMI ≤ 35.0
If anti-diabetic regime or lipid lowering drugs are used, they have to be stable andcontrolled for at least 2 months; regimes are expected to remain stable throughout theduration of the study or not being on anti-diabetic medication.
If on oral hypoglycaemic agent, participant should have the last dose at 8pm of theday before each study visit.
Willingness to comply with the study protocol, including:
Use of standard evening meal the day prior to the assessments
Refrain from alcohol consumption (24 h prior the visit) and extraneous physicalexercise (72 h prior to and during the assessments).
Not changing physical activity routine or dietary habits for the duration of the study (except from the standard evening meal).
Exclusion
Exclusion Criteria:
Not diagnosed with Type 2 Diabetes Mellitus
Mixed ancestors
Taking any of the following medications:
Insulin
Diabetic medication (except from Metformin or oral hypoglycaemic which are allowed).
Orlistat
Any gastrointestinal disease that interferes with bowel function and nutritionalintake (i.e. Diabetes related constipation or diarrhoea secondary to neuropathy orchronic inflammatory bowel disease, gastrectomy, etc.)
Significant heart (New York Heart Association class IV), hepatic (transaminase levelsgreater than 3 times normal) or renal disease (requiring dialysis)
Cancer
Pancreatitis
Major infections (requiring antibiotics) within 3 weeks before study entry
Concomitant therapy with acarbose, meglitinides, insulin, systemic glucocorticoids orwithin 2 weeks prior to study entry
History of alcohol and/or drug abuse
Investigator's uncertainty about the willingness or ability of patient to comply withthe protocol requirements
Participation in other nutrition trials within 3 months of study entry or drug trialswithin 5 months of study end
Current smokers
Allergic to test food or traces contained in the test food, breathing mould,penicillin, egg, soy
Asthmatics.
Any condition involving the imbalance of hormones
Hypothyroidism.
Weight change of ≥ 5% in the preceding 3 months
Shift workers
Vegetarian
Medical implants that require batteries such as heart pace makers
Study Design
Study Description
Connect with a study center
NIHR Imperial Clinical Research Facility
London, W12 0HS
United KingdomActive - Recruiting

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