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Completed

NCT Number: NCT04064203

The Effect of Insulin-induced Hypoglycaemia on Gut-derived Glucagon Secretion (Px-Hypo)

The overall objective of this study is to investigate whether hypoglycaemia (the most potent stimulus of pancreatic glucagon secretion) affects the secretion of gut-derived glucagon in totally pancreatectomized patients.

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Key information

Conditions

Diabetes After Total Pancreatectomy

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Clinical Metabolic Research

Hellerup, Capital Region, 2900, Denmark

About this study

The investigators want to assess the plasma glucagon response to insulin-induced hypoglycaemia in totally pancreatectomised patients and at the same time evaluate whether hypoglycaemia affects a range of other products from endocrine cells in the gastrointestinal tract including ghrelin, gastrin, cholecystokinin (CCK), glucose-dependent insulinotropic polypeptide (GIP), GLP-1, glucagon-like peptide-2 (GLP-2), oxyntomodulin and peptide YY (PYY). Furthermore the investigators will evaluate how hypoglycaemia in these patients affects other counter-regulatory mechanisms including plasma responses of the hormones adrenaline, noradrenaline, growth hormone and cortisol as well as the rate of gastric emptying rate (which under normal circumstances accelerates during hypoglycaemia) during an oral glucose tolerance test (OGTT).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Pancreatectomised patients

  • Caucasian above 30 years of age who have undergone total pancreatectomy
  • Blood haemoglobin >7.0 mmol/l for males and >6.5 mmol/l for females Non-diabetic control subjects
  • Normal fasting plasma glucose and normal HbA1c (according to the World Health Organization (WHO) criteria)
  • Normal blood haemoglobin
  • Caucasian above 30 years of age
  • BMI (body mass index) 17-30
  • Informed consent

Exclusion criteria

Pancreatectomised patients

  • Pancreatectomy within the last 3 months
  • Ongoing chemotherapy or chemotherapy within the last 3 months
  • Previous or ongoing treatment with GLP-1 receptor agonists or dipeptidyl peptidase 4 (DPP-4) inhibitors
  • Inflammatory bowel disease
  • Gastrointestinal resection (other than the gastro-duodenectomy performed in connection with total pancreatectomy) and/or ostomy
  • Nephropathy (eGFR<60 and/or albuminuria)
  • Known liver disease (excluding non-alcoholic fatty liver disease) and/or serum alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) >3 × normal values)
  • Severe lung disease
  • Pregnancy and/or breastfeeding
  • Age above 85 years
  • Uncontrolled hypertension and/or significant cardiovascular disease
  • Any condition that the investigator feels would interfere with trial participation Non-diabetic control subjects
  • Diabetes or prediabetes (according to WHO criteria)
  • First-degree relatives with diabetes
  • Inflammatory bowel disease
  • Gastrointestinal resection and/or ostomy
  • Nephropathy (serum creatinine >150 µmol/l and/or albuminuria)
  • Known liver disease (excluding non-alcoholic fatty liver disease) and/or serum ALAT and/or serum ASAT >3 × normal values)
  • Severe lung disease
  • Pregnancy and/or breastfeeding
  • Age above 85 years
  • Uncontrolled hypertension and/or significant cardiovascular disease
  • Any condition that the investigator feels would interfere with trial participation

Treatment and study plan

Oral glucose tolerance test

Other

50 grams OGTT

Clamp experiment

Other

insulin-induced hypoglycaemic clamp followed by an 50 grams OGTT

Primary outcomes

  1. p-glucagon

    Time frame: -30, -15, 0, 15, 40, 50, 60, 70, 80, 90, 105, 120, 135, 150, 165, 180, 210, 240 minutes

    Plasma glucagon excursions measured as incremental area under the curve (iAUC)

Secondary outcomes

  1. p-glucose

    Time frame: -30, -15, 0, 15, 40, 50, 60, 70, 80, 90, 105, 120, 135, 150, 165, 180, 210, 240 minutes

    plasma glucose excursions measured as incremental area under the curve (iAUC)

  2. GIP, GLP-1, GLP-2, GIP, oxyntomodulin, ghrelin, peptide YY, gastrin

    Time frame: -30, -15, 0, 15, 40, 50, 60, 70, 80, 90, 105, 120, 135, 150, 165, 180, 210, 240 minutes

    excursions in Gut hormones measured as incremental area under the curve (iAUC)

  3. catecholamines

    Time frame: -30, -15, 0, 15, 40, 50, 60, 70, 80, 90 minutes

    p-adrenaline and p-noradrenaline, excursions measured as incremental area under the curve (iAUC)

  4. cortisol

    Time frame: -30, -15, 0, 15, 40, 50, 60, 70, 80, 90 minutes

    p-cortisol excursions measured as incremental area under the curve (iAUC)

  5. growth hormone

    Time frame: -30, -15, 0, 15, 40, 50, 60, 70, 80, 90 minutes

    p-growth hormone excursions measured as incremental area under the curve (iAUC)

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Collaborators

  • University of Copenhagen

Registry information

Official study title

The Effect of Insulin-induced Hypoglycaemia on Gut-derived Glucagon Secretion

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 21, 2019
Registry last updated
Aug 21, 2019

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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