Postprandial Hypoglycemia Clinical Trial
— EFFECTOfficial title:
Glucose Response to a Formula for Patients at Risk of Hypoglycaemia
Verified date | June 2023 |
Source | Nutricia Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study assesses the glycemic responses to several nutritional products.
Status | Completed |
Enrollment | 18 |
Est. completion date | March 30, 2023 |
Est. primary completion date | March 30, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: 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). Exclusion Criteria: 1. Blood glucose levels = 7.8 mmol/L at screening (not fasted) 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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | EB UtrechtResearch BV | Utrecht |
Lead Sponsor | Collaborator |
---|---|
Nutricia Research |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Decline in glucose level after reaching peak (Cmax) | The decline in glucose (mmol/hour) after reaching peak glucose levels (Cmax) until reaching baseline (t = -5) blood glucose levels or, in case baseline blood glucose levels are not reached, the lowest observed blood glucose level. | 6 hours | |
Secondary | Incremental Area Under the Curve (iAUC) for glucose | Incremental Area Under the Curve (iAUC) for glucose (mmol/L/hrs) | 6 hours | |
Secondary | Incremental Area Under the Curve (iAUC) for insulin | Incremental Area Under the Curve (iAUC) for insulin (pmol/L/hrs) | 6 hours | |
Secondary | Incremental Area Under the Curve (iAUC) for paracetamol | Incremental Area Under the Curve (iAUC) for paracetamol (pmol/L/hrs) | 6 hours | |
Secondary | Incremental peak levels (iCmax) of glucose | Incremental peak levels (iCmax) of glucose (mmol/L) | 6 hours | |
Secondary | Incremental peak levels (iCmax) of insulin | Incremental peak levels (iCmax) of insulin (pmol/L) | 6 hours | |
Secondary | Incremental peak levels (iCmax) of paracetamol | Incremental peak levels (iCmax) of paracetamol (mg/L) | 6 hours | |
Secondary | Time to peak levels (Tmax) of glucose | Time to peak levels (Tmax) of glucose (min) | 6 hours | |
Secondary | Time to peak levels (Tmax) of insulin | Time to peak levels (Tmax) of insulin (min) | 6 hours | |
Secondary | Time to peak levels (Tmax) of paracetamol | Time to peak levels (Tmax) of paracetamol (min) | 6 hours |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03984370 -
Dasiglucagon in the Treatment of Postprandial Hypoglycaemia After Roux-en-Y Gastric Bypass
|
Phase 2 | |
Completed |
NCT03200782 -
Postprandial Hypoglycemia in Patients After Bariatric Surgery With Empagliflozin and Anakinra - The Hypo-BEAR-Study
|
N/A | |
Recruiting |
NCT05036317 -
Empagliflozin for the Treatment of Postprandial Hypoglycemia
|
Phase 3 | |
Active, not recruiting |
NCT05174507 -
Empagliflozin and Anakinra for the Treatment of Postprandial Hypoglycemia in Patients With Prediabetes
|
Phase 2 | |
Completed |
NCT04330196 -
Effect of Postprandial Hyperinsulinaemic Hypoglycaemia on Driving Performance.
|
N/A | |
Recruiting |
NCT04720859 -
Canagliflozin in Postprandial Hyperinsulinemic Hypoglycemia (CANA-PHH-RYGB)
|
N/A | |
Completed |
NCT04836273 -
Treatment of Post-bariatric Hypoglycaemia
|
Phase 2 | |
Completed |
NCT05513404 -
The Scottish Fruit Study
|
N/A | |
Completed |
NCT01162499 -
Role of Glucagon-Like Peptide-1 in Postprandial Hypoglycemia
|
N/A | |
Recruiting |
NCT05401578 -
Canakinumab for the Treatment of Postprandial Hypoglycemia
|
Phase 3 |