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Completed

NCT Number: NCT04613700

The Role of Secretin on the Energy Homeostasis

As of last year, new insight into the function of secretin was brought about as rodent studies showed secretin to possess potential body weight-regulating effects. In these studies, secretin was shown to increase non-shivering thermogenesis in brown adipose tissue (BAT), decrease meal size and promote meal discontinuation. The mechanisms behind these regulatory effect of secretin on energy homeostasis are unclear,

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Key information

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Herlev- Gentofte Hospital, Center for Clinical Metabolic Research

Hellerup, Copenhagen, 2900, Denmark

About this study

Secretin was - as the first hormone - identified in 19021, but was not isolated until the 1960s. Secretin is produced in and secreted form small intestinal S cells. In the 1970s, the primary endocrine effects of secretin were unequivocally confirmed, namely potentiation of bicarbonate and pepsin secretion from the pancreas as well as stimulation of bile production in the liver. In the 1990s, the biosynthesis of secretin was delineated and its receptor was discovered. In the 2000s the pancreatic regulation of intestinal pH was shown to be secretin-mediated. As of last year, new insight into the function of secretin was brought about as rodent studies showed secretin to possess potential body weight-regulating effects. In these studies, secretin was shown to increase non-shivering thermogenesis in brown adipose tissue (BAT), decrease meal size and promote meal discontinuation.

The primary aim of this study is to evaluate the effect of a 5-hour intravenous infusion with the naturally occurring hormone secretin on ad libitum food intake (primary endpoint) compared to a double-blinded placebo (isotonic saline) infusion in 25 healthy young males.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age between 18 and 75 years
  • Body mass index between 18.5 and 27.5 kg/m2
  • Informed consent
  • Body weight above 50 kg

Exclusion criteria

  • Anaemia (blood haemoglobin below normal range)
  • Known liver disease and/or alanine aminotransferase and/or aspartate transaminase > 2 times upper normal values
  • Nephropathy (serum creatinine above normal range and/or albuminuria)
  • Clinically significant kidney function impairment or other laboratory findings leading to the diagnosis of clinically relevant disorders (thyroid dysfunction, anaemia etc)
  • Any physical or psychological condition that the investigators feel would interfere with trial participation

Treatment and study plan

Secretin

Drug

Native hormone

Placebo

Other

Saline

Primary outcomes

  1. Food intake on ad libitum meal

    Time frame: 300 minutes

    Kilojoule

  2. Duration of ad libitum meal

    Time frame: 300 minutes

    Duration in minutes

Secondary outcomes

  1. Water intake during ad libitum meal

    Time frame: 300 minutes

    mL

  2. resting energy expenditure

    Time frame: Baseline, 90 minutes and 270 minutes

    Indirect calorimetry of respiration

  3. Supraclavicular Brown adipose activity

    Time frame: -15 to 15 , 90 and 270 minutes

    Evaluated by neck skin temperature assessed using a non-invasive thermal imaging camera)

  4. Appetite and satiety sensations (assessed by VASs),

    Time frame: Every 15 minutes after infusion, until time-point 90, hereafter every 30 minutes

    Visual analogue scales with a scale of 1-10 (Direction of scale varies)

  5. Heart rate

    Time frame: every 15 minutes from from -15 to 300 minutes

    heart rate .

  6. systolic blood pressure

    Time frame: every 15 minutes from from -15 to 300 minutes

    Systolic blood pressure

  7. Diastolic blood pressure

    Time frame: every 15 minutes from from -15 to 300 minutes

    Diastolic blood pressures

  8. Gallbladder motility

    Time frame: Timepoint -30, 10,20,45,60,75,90,120,210,300 minutes

    Gallbladder motility measured by Ultrasound

Sponsors and collaborators

Lead sponsor

Steno Diabetes Center Copenhagen

Other

Registry information

Acronym: THE-ROSE

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Nov 3, 2020
Registry last updated
Nov 5, 2020

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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