Effect of Smoking on Postprandial Gastric Emptying, Glucose Tolerance and Secretion of Gut and Pancreatic Hormones (SmokinGLP-1)

University Hospital, Gentofte, Copenhagen

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Other: Skin Biopsy; Dietary Supplement: Liquid mixed meal

Study type: Interventional

Funder types: Other

Identifiers

NCT02497651

h-1-2013-042

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Healthy, heavy smoking men

Experimental group

Description:

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

Treatment:

Other: Skin Biopsy

Dietary Supplement: Liquid mixed meal

Healthy, non-smoking men

Experimental group

Description:

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

Treatment:

Other: Skin Biopsy

Dietary Supplement: Liquid mixed meal