Phase
Condition
Diabetes And Hypertension
Diabetes Mellitus, Type 2
Diabetes Mellitus Types I And Ii
Treatment
WheyBasics
BetaQuik™
Iso-voluminous water
Clinical Study ID
Ages 25-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female subjects, 25 to 65 years of age, inclusive.
Subjects with a BMI of ≤ 40kg/m2.
Established diagnosis of Type 2 diabetes mellitus (T2DM), documented by either HbA1c 6.5 -10.0% or active therapy with metformin at a daily dose of up to 3000 mg atscreening.
Willing and able to sign written informed consent prior to study entry.
Subjects with laboratory parameters within normal range, or showing no clinicallyrelevant deviations, as judged by the investigator.
Willing and able to comply with the requirements of the study protocol.
Exclusion
Exclusion Criteria:
Fasting blood glucose >11mmol/L at screening.
Elevated liver transaminases > 3 Upper limit of normal at screening.
Ongoing or recent (i.e. < 3month) insulin therapy.
Ongoing or recent (i.e. < 3month) GLP-1 therapy.
Ongoing or recent (i.e. < 3month) treatment with any oral or injectableglucose-lowering drug other than metformin.
Ongoing or recent weight loss interventions (e.g. dietary weight loss programmes) orany history of bariatric surgery.
Ongoing treatment with anorectic drugs, steroids, medications known to affectgastric motility, or any condition known to affect gastro-intestinal integrity andfood absorption.
Major medical/surgical event requiring hospitalization in the last 3 months.
Known allergy and intolerance to product components.
Alcohol intake higher than 4 units per day in line with National Health Serviceguidelines.
History of regular smoking (daily or most days in a week) or use of nicotineproducts (3 or more nicotine containing products).
Have a hierarchical link with the research team members.
Subjects who have been dosed in another clinical trial with any investigationaldrug/new chemical entity within 3 months or 5 half-lives (whichever is longer) priorto screening, or subjects currently participating in any investigational trial.
Positive pregnancy test at screening for women of child-bearing potential.
Subject who, in the judgment of the investigator, is likely to be noncompliant oruncooperative during the study due to language barrier, poor mental development orany other reason.
Subjects with fasting blood glucose that is not within 20% of the value at theprevious study visit. Note: In such cases, subjects can come in on another daywithin the visit window at the discretion of the investigator, however, subjectswill be discontinued if the same observation is made at the new visit.
Evidence of eating disorders and regularly skipping breakfast and dinner.
Current or recent history (in last 3 months) of clinically significantgastrointestinal, liver, cardiovascular, clotting, metabolic or endocrine disorders,apart from T2DM, that in the opinion of the investigator might put the subject atrisk by entering the study or interfere with the aims of the study.
Total score of ≥ 20 on the Eating Attitude Test (EAT-26) at the screening visit.
Study Design
Study Description
Connect with a study center
University of Nottingham
Nottingham,
United KingdomSite Not Available

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