Overview

This trial has been completed.

Condition diabetes mellitus
Treatments liquid mixed meal, skin biopsy
Sponsor University Hospital, Gentofte, Copenhagen
Collaborator University of Copenhagen
Start date May 2015
End date October 2015
Trial size 24 participants
Trial identifier NCT02497651, h-1-2013-042

Summary

The study aims to evaluate the effect of smoking on postprandial responses such as plasma glucose, secretion of gut - and pancreatic hormones and gastric emptying in healthy, heavy smoking men.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose basic science
Arm
(Experimental)
Twelve healthy, male subjects. Intervention: Will undergo two separate, identical test days. One absent smoking, and one with concomitant smoking.
liquid mixed meal
The subjects will ingest a 400 ml chocolate drink, rich on carbohydrates, fat and lipids. In the following 4 hours, blood samples will be drawn from a PVC for the measurement of plasma glucose, gut- and pancreatic hormones, acetaminophen etc. After the 4 hours, the subjects will be offered an ad libitum meal.
skin biopsy
All subjects will undergo a skin biopsy procedure. Two small (3 mm) biopsies will be taken from the hip area under local anaesthesia. Standard wound treatment will follow.
(Experimental)
Twelve healthy, male subjects. Intervention: Will undergo a liquid mixed meal test and a skin biopsy.
liquid mixed meal
The subjects will ingest a 400 ml chocolate drink, rich on carbohydrates, fat and lipids. In the following 4 hours, blood samples will be drawn from a PVC for the measurement of plasma glucose, gut- and pancreatic hormones, acetaminophen etc. After the 4 hours, the subjects will be offered an ad libitum meal.
skin biopsy
All subjects will undergo a skin biopsy procedure. Two small (3 mm) biopsies will be taken from the hip area under local anaesthesia. Standard wound treatment will follow.

Primary Outcomes

Measure
Postprandial response of glucagon-like peptide-1 (GLP-1)
time frame: -30, -20, -10, 0, 10, 20, 30, 50, 70, 90, 120, 150, 180, 240 minutes (meal tests start at 0 min)

Secondary Outcomes

Measure
Postprandial response of insulin
time frame: -30, -20, -10, 0, 10, 20, 30, 50, 70, 90, 120, 150, 180, 240 minutes (meal tests start at 0 min)
Postprandial response of Glukagon
time frame: -30, -20, -10, 0, 10, 20, 30, 50, 70, 90, 120, 150, 180, 240 minutes (meal tests start at 0 min)
Postprandial response of CCK
time frame: -30, -20, -10, 0, 10, 20, 30, 50, 70, 90, 120, 150, 180, 240 minutes (meal tests start at 0 min)
Postprandial response of Gastrin
time frame: -30, -20, -10, 0, 10, 20, 30, 50, 70, 90, 120, 150, 180, 240 minutes (meal tests start at 0 min)
Postprandial response of GIP
time frame: -30, -20, -10, 0, 10, 20, 30, 50, 70, 90, 120, 150, 180, 240 minutes (meal tests start at 0 min)
Postprandial increment in plasma glucose
time frame: -30, -20, -10, 0, 10, 20, 30, 50, 70, 90, 120, 150, 180, 240 minutes (meal tests start at 0 min)
Blood Inflammatory and metabolic markers (composite)
time frame: -30, -20, -10, 0, 10, 20, 30, 50, 70, 90, 120, 150, 180, 240 minutes (meal tests start at 0 min)
Gall bladder volume
time frame: -30, 20, 40, 80, 240 minutes (meal tests start at 0 min)
Gastric emptying
time frame: -30, -20, -10, 0, 10, 20, 30, 50, 70, 90, 120, 150, 180, 240 minutes (meal tests start at 0 min
GLP-1 receptor expression in the skin
time frame: After the 240 minutes

Eligibility Criteria

Male participants at least 18 years old.

Inclusion Criteria: - Both groups - Caucasian ethnicity - Healthy males - Normal haemoglobin - Age above 18 years - Informed and written consent - BMI >20 kg/m2 Smokers • Minimum 20 cigarettes pr. day for at least 1 year Non-smokers • No smoking on a regular basis Exclusion Criteria: - Both groups - Diabetes or prediabetes (fasting plasma glucose levels >6.5 mM or HbA1c >6.0%) - First- or second-degree relatives with diabetes - Liver disease (alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) >2 times normal values) or history of hepatobiliary disorder - Gastrointestinal disease, previous intestinal resection, cholecystectomy or any major intra-abdominal surgery - Hypo- or hyperphosphataemia - Nephropathy (serum creatinine >150 µM and/or albuminuria - Treatment with medicine that cannot be paused for 12 hours - Hypo- or hypercalcaemia - Hypo- and hyperthyroidism - Treatment with oral anticoagulants - Active or recent malignant disease - Any treatment or condition requiring acute or sub-acute medical or surgical intervention - Any condition considered incompatible with participation by the investigators

Additional Information

Description Epidemiological studies show that active smoking increases the risk of type 2 diabetes in a dose-dependent fashion. Smokers seem to be characterized by central obesity, increased inflammatory markers and oxidative stress, which may lead to insulin resistance and irregularities in glucose metabolism. The current study is a meal test study, in which the aim is to examine a number of variables during a liquid mixed meal test (including gastric emptying, glucose tolerance, gut and pancreatic hormone responses, gall bladder emptying, appetite and food intake) performed in healthy non-smoking subjects and in healthy smokers with or without concomitant cigarette smoking. The investigators hypothesize that smoking-induced increases in circulating nicotine levels and simultaneous activation of nicotinic receptors in the gastrointestinal tract and in the autonomic nervous system would have detrimental effect on postprandial glucose metabolism and, thus, constitute an important link between smoking and the risk of type 2 diabetes. The current study will help to clarify this hypothesis and improve our general understanding of the association between smoking and gut hormone secretion, gastric emptying and glucose metabolism.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University Hospital, Gentofte, Copenhagen.