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NCT Number: NCT04782999

Effect of RYGB on Alpha- and Beta Cell Function and Sensitivity to Incretins in Patients With Type 2 Diabetes

The aim of the study is to investigate the effect of Roux-en-Y gastric bypass (RYGB) on pancreatic alpha and beta-cell function and for the sensitivity of incretin hormones in patients with pre-operative type 2 diabetes.

Primary hypotheses:

* After RYGB, the sensitivity to GLP-1 and GIP is improved (improved insulinotropic effect). * After RYGB, the insulin secretion improves during an oral glucose tolerance test within 3 months postoperatively. * After RYGB, the insulin secretion during intraveneous stimulation with glucose or non-glucose (arginin) is unchanged.

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Key information

Conditions

Type2 Diabetes Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hvidovre University Hospital

Hvidovre, Denmark

About this study

Design: 12 patients with type 2 diabetes will be recruited.

All subjects will undergo 11 study visits: four visits before, three visits at 1 week after surgery and four visits at 3 months postoperatively:

  • Oral glucose tolerance tests (OGTTs) with measurement of GLP-1 and GIP secretion will be performed before and 3 months post-surgery.
  • Hyperglycemic clamps with co-infusion of saline, GLP-1 or GIP will be performed in a randomised order at three separate study visits in randomized order before, 1 week and 3 months after surgery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Inclusion criteria for RYGB in Denmark (ie. BMI > 35 in the presence of obesity related co-morbidities as type 2 diabetes)
  • Type 2 diabetes
  • Pre-operative: Fasting plasma glucose ≥7,0 mmol/L or 2 hour plasma glucose ≥ 11,1 mmol/L (after pausing antidiabetic medication for a minimum of 3 days)
  • Written informed consent.

Exclusion criteria

  • Exclusion criteria for RYGB (psychiatric illness, obesity triggered by medical treatment for psychiatric illness, mental retardation, alcohol or drug abuse, severe heart-lung disease despite optimal medical treatment, previous serious problems with universal anesthesia, previous peritonitis, large hiatus hernia, diseases of the ventricle / previously complicated upper abdominal surgery, recurrent esophagitis, poor compliance).
  • Type 2 diabetes where antidiabetic medication cannot be paused for 3 days.
  • Pregnancy and breast-feeding.
  • Hemoglobin <7.0 mmol/L

Treatment and study plan

Oral glucose tolerance test

Diagnostic Test

Standard test of glucose tolerance with ingestion of 75 g glucose followed by blood sampling.

Hyperglycemic clamp with infusion of saline, GLP-1 or GIP

Diagnostic Test

Blood glucose kept at 15 mmol/L via iv 20% glucose infusions.

Primed co-infusion of either:

  • Saline
  • GLP-1 (Prime dose 6 pmol/kg, infusion 1 pmol/kg/min)
  • GIP (Prime dose 3 pmol/kg, infusion 1.5 pmol/kg/min).

Primary outcomes

  1. Insulinotropic effects of GLP-1 and GIP

    Time frame: Change from before to 1 week and 3 months after RYGB

    Insulin secretion during steady state of all hyperglycemic clamps

  2. Insulin secretion during oral stimulation

    Time frame: Change from before to 3 month after RYGB

    AUC of C-peptide during oral glucose tolerance test

  3. Insulin secretion during iv stimulation

    Time frame: Change from before to 1 week and 3 months after RYGB

    Insulin secretion during hyperglycemic clamp with saline infusion and during argininine iv stimulation test

Secondary outcomes

  1. Alpha cell function

    Time frame: Change from before to after 1 week and 3 months after RYGB

    Glucagon secretion during hyperglycemic clamps

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Collaborators

  • University of Copenhagen

Registry information

Acronym: BETASIN

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
Mar 4, 2021
Registry last updated
Mar 16, 2022

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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