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Completed

NCT Number: NCT02497651

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

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.

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Key information

Conditions

Diabetes Mellitus Behavior Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Smoking

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Center for Diabetes Research, Department of Medicine, Gentofte Hospital

Hellerup, Copenhagen, 2900, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Liquid mixed meal

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

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.

Primary outcomes

  1. 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)

    Incremental and total area under the Concentration-Time Curve (AUC 0-240 min)

Secondary outcomes

  1. 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)

    Incremental and total area under the Concentration-Time Curve (AUC 0-240 min)

  2. 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)

    Incremental and total area under the Concentration-Time Curve (AUC 0-240 min)

  3. 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)

    Incremental and total area under the Concentration-Time Curve (AUC 0-240 min)

  4. 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)

    Incremental and total area under the Concentration-Time Curve (AUC 0-240 min)

  5. 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)

    Incremental and total area under the Concentration-Time Curve (AUC 0-240 min)

  6. 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)

    Incremental and total area under the Concentration-Time Curve (AUC 0-240 min)

  7. 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)

  8. Gall bladder volume

    Time frame: -30, 20, 40, 80, 240 minutes (meal tests start at 0 min)

    Assessment of gall bladder volume will be mediated by ultrasound

  9. 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

    Measurement of acetaminophen is taken as a measure of gastric emptying

  10. GLP-1 receptor expression in the skin

    Time frame: After the 240 minutes

    Analysis of the skin cells from the biopsies.

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Collaborators

  • European Foundation for the Study of Diabetes
  • University of Copenhagen

Registry information

Acronym: SmokinGLP-1

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Jul 14, 2015
Registry last updated
Aug 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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