Glucose Response to a Formula for Patients at Risk of Hypoglycaemia

Postprandial Hypoglycemia Clinical Trial

— EFFECT  

Official title:

Glucose Response to a Formula for Patients at Risk of Hypoglycaemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05676385
• Other study ID #: SBB22R&52507
• Status: Completed
• Phase: N/A
• Start date: February 13, 2023
• Est. completion date: March 30, 2023

Study information

• Verified date: June 2023
• Source: Nutricia Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study assesses the glycemic responses to several nutritional products.

Description:

During a study visit fasted subjects will consume one serving of the reference product or of the test products. Venous blood samples will be taken at baseline and at several time-points over a 6-hr period.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Hypoglycemia
• Postprandial Hypoglycemia

Intervention

Dietary Supplement:
• First concept product (containing 50 grams of carbohydrates)
Fasted intake of First concept product (randomised)
• Second concept product (containing 50 grams of carbohydrates)
Fasted intake Second concept product (randomised)
• Reference product (containing 50 grams of carbohydrates)
Fasted intake of Reference product (randomised)

Locations

Country	Name	City	State
Netherlands	EB UtrechtResearch BV	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
Nutricia Research

Country where clinical trial is conducted

Netherlands, 

Outcome

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