Secretin Activates Human Brown Fat and Induces Satiation.

NCT03290846 | Completed Phase 2

• 1 other identifier: T153/2016
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

15 healthy males will be studied with PET/CT, using FDG to investigate glucose metabolism, and radiowater to investigate perfusion. One scan will be performed in controlled cold exposure, to see whether subjects have cold activated brown adipose tissue. Two scans will be performed in room temperature conditions, where all subjects are blinded and randomised to receive placebo and secretin hydrochloride. PET/CT scans will be analysed blinded. 20 healthy males will also be studied with fMRI, in order to investigate brain activity responses to appetizing versus bland foods. This study will be conduced on the same patients as the PET/CT study, but additional subjects with same inclusion and exclusion criteria will be recruited. Two fMRI scans will be performed in room temperature conditions, where all subjects are blinded and randomised to receive placebo and secretin hydrochloride. fMRI scans will be analysed blinded.

Conditions

Obesity

Outcome Measures

Primary Outcomes (3)

• Secretin activates brown fat

  Secretin increases brown adipose tissue glucose uptake compared to placebo. This is studied with PET/CT, using a glucose tracer.

  Effect within one hour

• Secretin activates brown fat

  Secretin increases brown adipose tissue flow compared to placebo. This is studied with PET/CT, using a radiowater tracer.

  Effect within six minutes

• Secretin induces satiation

  Secretin attenuates brain activity, when subjects are viewing palatable vs. non-palatable food images.

  Effect within one hour

Secondary Outcomes (3)

• Secretin increases whole body energy expenditure

  Effect within two hours

• Secretin induces satiety

  Effect within three hours

• Secretin reduces food consumption.

  Within three days

Other Outcomes (2)

• Secretin induces changes in biomarkers and metabolites.

  Within two hours

• Brown adipose tissue biopsies.

  Within 2 months

Study Arms (1)

Secretin study

EXPERIMENTAL

PET and MRI scannings will be performed twice. Subjects will be given secretin hydrochloride and placebo on separate days. In addition, subjects will undergo cold exposure PET scanning once.

Drug: Secretin Human; Drug: Saline Solution; Other: Cold exposure

Interventions

Secretin Human DRUG

Randomized, single-blinded secretin hydrochloride infusion.

Secretin study

Saline Solution DRUG

Randomized, single-blinded saline infusion.

Secretin study

Cold exposure OTHER

All subjects will undergo a cold exposure PET scan.

Secretin study

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Radiation exposure for fertile women is avoided
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy normal weight

You may not qualify if:

• cardiovascular disease, diabetes
• smoking

Sponsors & Collaborators

• Turku University Hospital: lead
• Technical University of Munich: collaborator

Study Sites (1)

Turku PET Centre

Turku, 20521, Finland

Location

Related Publications (3)

• Sun L, Laurila S, Lahesmaa M, Rebelos E, Virtanen KA, Schnabl K, Klingenspor M, Nummenmaa L, Nuutila P. Secretin modulates appetite via brown adipose tissue-brain axis. Eur J Nucl Med Mol Imaging. 2023 May;50(6):1597-1606. doi: 10.1007/s00259-023-06124-4. Epub 2023 Feb 11.

  PMID: 36764966 DERIVED

• Laurila S, Rebelos E, Lahesmaa M, Sun L, Schnabl K, Peltomaa TM, Klen R, U-Din M, Honka MJ, Eskola O, Kirjavainen AK, Nummenmaa L, Klingenspor M, Virtanen KA, Nuutila P. Novel effects of the gastrointestinal hormone secretin on cardiac metabolism and renal function. Am J Physiol Endocrinol Metab. 2022 Jan 1;322(1):E54-E62. doi: 10.1152/ajpendo.00260.2021. Epub 2021 Nov 22.

  PMID: 34806426 DERIVED

• Laurila S, Sun L, Lahesmaa M, Schnabl K, Laitinen K, Klen R, Li Y, Balaz M, Wolfrum C, Steiger K, Niemi T, Taittonen M, U-Din M, Valikangas T, Elo LL, Eskola O, Kirjavainen AK, Nummenmaa L, Virtanen KA, Klingenspor M, Nuutila P. Secretin activates brown fat and induces satiation. Nat Metab. 2021 Jun;3(6):798-809. doi: 10.1038/s42255-021-00409-4. Epub 2021 Jun 21.

  PMID: 34158656 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Secretin; Saline Solution

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Pirjo R Nuutila, MD,PhD

  Turku UH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: Participants receive drug and placebo infusion without knowing which day is which.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD PhD

Model Details: Single blinded randomised study, secretin infusion is given on one day, saline infusion on an other day.

Study Record Dates

• First Submitted: September 19, 2017
• First Posted: September 25, 2017
• Study Start: August 2, 2016
• Primary Completion: October 30, 2019
• Study Completion: November 30, 2019
• Last Updated: December 23, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)