Studies of the Early Meal Phase in Healthy Individuals - Nutrient Absorption and Gastrointestinal Hormone Secretion

University of Copenhagen

Status: Unknown

Conditions: Healthy

Treatments: Other: Liquid mixed meal test; Other: Oral glucose tolerance test

Study type: Interventional

Funder types: Other

Identifiers

NCT03543423

UC/RH-early phase

Details and patient eligibility

About

To investigate gastrointestinal hormone secretions and nutrient absorption during the early meal phase we will recruit 12 healthy young men. They will be equipped with peripheral intravenous catheters for frequent blood sampling. Participants will be screened and acclimatised to the study situation on visit 1. On visit 2 and 3 participants will in random order ingest an oral glucose solution or a standardised liquid mixed meal over 2-3 min.

Enrollment: 12 estimated patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age between 18 and 40years
• Male
• Normal Haemoglobin concentration
• Informed consent

Exclusion criteria

• Diabetes mellitus
• Family history of diabetes mellitus
• intestinal disease (for example inflammatory bowel disease or malabsorption)
• Family history of inflammatory bowel disease
• Previous intestinal resection (except uncomplicated appendicectomy)
• Body mass index (BMI) > 25 kg/m2
• Tobacco use
• kidney disease (se-creatinine> 130 µM and/or albuminuria)
• liver disease (ALAT and/or ASAT >2 × above normal range)
• Heart disease
• Treatment with drugs
• History of constipation
• Conditions with delayed or accelerated gastric emptying
• Latex or other allergies
• Bleeding diathesis

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Oral glucose tolerance test

Experimental group

Description:

Intervention: oral glucose tolerance test (75 gram glucose supplemented with 5g 3-OMG and 1g paracetamol) ingested over 2 min.

Treatment:

Other: Oral glucose tolerance test

Liquid mixed meal test

Experimental group

Description:

Intervention: Standardised liquid mixed meal (supplemented with 1g paracetamol) ingested over 2min

Treatment:

Other: Liquid mixed meal test