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

NCT ID: NCT02497651

Last Updated: 2017-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2016-06-30

Brief 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.

Detailed 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.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Healthy, heavy smoking men

Twelve healthy, male subjects. Intervention: Will undergo two separate, identical test days. One absent smoking, and one with concomitant smoking.

Group Type: EXPERIMENTAL

Liquid mixed meal

Intervention Type: DIETARY_SUPPLEMENT

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

Intervention Type: OTHER

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.

Healthy, non-smoking men

Twelve healthy, male subjects. Intervention: Will undergo a liquid mixed meal test and a skin biopsy.

Group Type: EXPERIMENTAL

Liquid mixed meal

Intervention Type: DIETARY_SUPPLEMENT

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

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Copenhagen

OTHER

Sponsor Role: collaborator

European Foundation for the Study of Diabetes

OTHER

Sponsor Role: collaborator

University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Filip Krag Knop

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Center for Diabetes Research, Department of Medicine, Gentofte Hospital

Hellerup, Copenhagen, Denmark

Countries

Denmark

References

Grondahl MF, Bagger JI, Lund A, Faurschou A, Rehfeld JF, Holst JJ, Vilsboll T, Knop FK. Effects of Smoking Versus Nonsmoking on Postprandial Glucose Metabolism in Heavy Smokers Compared With Nonsmokers. Diabetes Care. 2018 Jun;41(6):1260-1267. doi: 10.2337/dc17-1818. Epub 2018 Mar 30.

Reference Type: DERIVED

PMID: 29602793 (View on PubMed)

Other Identifiers

h-1-2013-042

Identifier Type: -

Identifier Source: org_study_id