Glucose response to a formula for patients at risk of hypoglycaemia
- Conditions
- not applicable10018424
- Registration Number
- NL-OMON51388
- Lead Sponsor
- utricia Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
1. Healthy individuals, 18 up to and including 50 years of age.
2. Willing to maintain habitual diet, physical activity pattern, and body
weight throughout the trial.
3. Willing to avoid the consumption of alcohol, unusual food intake, unusual
physical activity 24h prior to each study visit.
4. Willing to come to the study visit in the morning after an overnight fast of
minimum 10 hours and maximum 14 hours (with water only).
1. Abnormal blood glucose levels at screening (not fasted) in the opinion of
the investigator.
2. Known history of gastrointestinal disease (e.g., diverticulitis, Crohn*s
disease, coeliac disease etc.), bariatric surgery, AIDS, hepatitis, a history
or presence of clinically important endocrine (including Type 1 or Type 2
diabetes mellitus), or any condition which might, in the opinion of the
Principal Investigator either: 1) make participation dangerous to the subject
(e.g. anaemia) or to others, or 2) affect the results.
3. Use of medications known to influence carbohydrate metabolism,
gastrointestinal function or appetite, including, but not limited to adrenergic
blockers, diuretics, thiazolidinediones, metformin and systemic corticosteroids
within 4 weeks of the screening visit, or any medication which might, in the
opinion of the Principal Investigator either: 1) make participation dangerous
to the subject or to others, or 2) affect the results.
4. Use of medications known to influence gastric emptying (including but not
limited to anticholinergics, nicotine, narcotic analgesics, ganglion blocking
drugs, antacids and metoclopramide).
5. Use of anti-clotting medications.
6. Current tobacco smokers or smokers that quite smoking < 1 month prior to
screening (except for occasional (<= 3) cigarettes/cigars/pipes per week on
average over the past month).
7. Self-reported pregnancy or breastfeeding.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome parameter in this study is the rate of decline in glucose<br /><br>(mmol/hour) after reaching peak glucose levels (Cmax) until reaching baseline<br /><br>(t = -5) blood glucose levels or, in case baseline blood glucose levels are not<br /><br>reached, the lowest observed blood glucose level.</p><br>
- Secondary Outcome Measures
Name Time Method <p>• incremental Area Under the Curve (iAUC) for:<br /><br>o glucose (mmol/L/hrs)<br /><br>o insulin (pmol/L/hrs)<br /><br>o paracetamol (mg/L/hrs)<br /><br><br /><br>• incremental peak levels (iCmax) of:<br /><br>o glucose (mmol/L)<br /><br>o insulin (pmol/L)<br /><br>o paracetamol (mg/L)<br /><br><br /><br>• time to peak levels (Tmax) of:<br /><br>o glucose (min)<br /><br>o insulin (min)<br /><br>o paracetamol (min)</p><br>