Effect of Smoking on Postprandial Gastric Emptying, Glucose Tolerance and Secretion of Gut and Pancreatic Hormones

Diabetes Mellitus Clinical Trial

— SmokinGLP-1  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02497651
• Other study ID #: h-1-2013-042
• Status: Completed
• Phase: N/A
• First received: June 25, 2015
• Last updated: August 4, 2017
• Start date: May 2015
• Est. completion date: June 2016

Study information

• Verified date: August 2017
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Dietary Supplement:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
Denmark	Center for Diabetes Research, Department of Medicine, Gentofte Hospital	Hellerup	Copenhagen

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen	European Foundation for the Study of Diabetes, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial response of glucagon-like peptide-1 (GLP-1)	Incremental and total area under the Concentration-Time Curve (AUC 0-240 min)	-30, -20, -10, 0, 10, 20, 30, 50, 70, 90, 120, 150, 180, 240 minutes (meal tests start at 0 min)
Secondary	Postprandial response of insulin	Incremental and total area under the Concentration-Time Curve (AUC 0-240 min)	-30, -20, -10, 0, 10, 20, 30, 50, 70, 90, 120, 150, 180, 240 minutes (meal tests start at 0 min)
Secondary	Postprandial response of Glukagon	Incremental and total area under the Concentration-Time Curve (AUC 0-240 min)	-30, -20, -10, 0, 10, 20, 30, 50, 70, 90, 120, 150, 180, 240 minutes (meal tests start at 0 min)
Secondary	Postprandial response of CCK	Incremental and total area under the Concentration-Time Curve (AUC 0-240 min)	-30, -20, -10, 0, 10, 20, 30, 50, 70, 90, 120, 150, 180, 240 minutes (meal tests start at 0 min)
Secondary	Postprandial response of Gastrin	Incremental and total area under the Concentration-Time Curve (AUC 0-240 min)	-30, -20, -10, 0, 10, 20, 30, 50, 70, 90, 120, 150, 180, 240 minutes (meal tests start at 0 min)
Secondary	Postprandial response of GIP	Incremental and total area under the Concentration-Time Curve (AUC 0-240 min)	-30, -20, -10, 0, 10, 20, 30, 50, 70, 90, 120, 150, 180, 240 minutes (meal tests start at 0 min)
Secondary	Postprandial increment in plasma glucose	Incremental and total area under the Concentration-Time Curve (AUC 0-240 min)	-30, -20, -10, 0, 10, 20, 30, 50, 70, 90, 120, 150, 180, 240 minutes (meal tests start at 0 min)
Secondary	Blood Inflammatory and metabolic markers (composite)		-30, -20, -10, 0, 10, 20, 30, 50, 70, 90, 120, 150, 180, 240 minutes (meal tests start at 0 min)
Secondary	Gall bladder volume	Assessment of gall bladder volume will be mediated by ultrasound	-30, 20, 40, 80, 240 minutes (meal tests start at 0 min)
Secondary	Gastric emptying	Measurement of acetaminophen is taken as a measure of gastric emptying	-30, -20, -10, 0, 10, 20, 30, 50, 70, 90, 120, 150, 180, 240 minutes (meal tests start at 0 min
Secondary	GLP-1 receptor expression in the skin	Analysis of the skin cells from the biopsies.	After the 240 minutes