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

NCT02497651 | Completed DMC

• 1 other identifier: h-1-2013-042
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Keywords

Smoking; Diabetes; Incretin hormones; Glucose tolerance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Postprandial response of insulin

  -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

  -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

  -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

  -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

  -30, -20, -10, 0, 10, 20, 30, 50, 70, 90, 120, 150, 180, 240 minutes (meal tests start at 0 min)

Study Arms (2)

Healthy, heavy smoking men

EXPERIMENTAL

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

Dietary Supplement: Liquid mixed meal; Other: Skin Biopsy

Healthy, non-smoking men

EXPERIMENTAL

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

Dietary Supplement: Liquid mixed meal; Other: Skin Biopsy

Interventions

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.

Healthy, heavy smoking men; Healthy, non-smoking men

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.

Healthy, heavy smoking men; Healthy, non-smoking men

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Gentofte, Copenhagen: lead
• University of Copenhagen: collaborator
• European Foundation for the Study of Diabetes: collaborator

Study Sites (1)

Center for Diabetes Research, Department of Medicine, Gentofte Hospital

Hellerup, Copenhagen, 2900, Denmark

Location

Related Publications (1)

• 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.

  PMID: 29602793 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Smoking

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 25, 2015
• First Posted: July 14, 2015
• Study Start: May 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: June 1, 2016
• Last Updated: August 7, 2017

Record last verified: 2017-08

Locations

DK (1)