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Trial · Interventional

Status unknownNot applicableRegistry data

Exercise and GLP-1 RA on Insulin Secretion

Short name EXISECRET

NCTNCT04383197 (opens ClinicalTrials.gov in a new tab)Other idH-19008233
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Not applicable
Enrollment
30 participants (estimated)
Sponsor
University of Copenhagen · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Denmark

Start
10 Dec 2019
Primary completion
Aug 2021 (estimated)
Completion
Aug 2022 (estimated)
First posted
12 May 2020
Last update posted
11 Feb 2021
Conditions
Type 2 Diabetes

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20192020202120222023
  1. N/A

    EXISECRET

    NCT04383197

    10 Dec 2019 to est. Aug 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this study is to determine the effect of endurance exercise on insulin secretory capacity, alone or in addition to treatment with the glucagon-like-peptide receptor agonist semaglutide, in patients with type 2 diabetes.

Interventions

  • Endurance exercise trainingBehavioral
  • SemaglutideDrug

Arms3

  • Experimental

    Semaglutide treatment

    3 months of therapeutic semaglutide treatment

  • Experimental

    Semaglutide and Endurance exercise

    12 weeks of endurance exercise concomitant to semaglutide treatment

  • Experimental

    Endurance exercise

    12 weeks of endurance exercise

Primary outcomes3

Outcomes the sponsor listed as primary.

  1. Insulin secretion

    Time frame · Change from baseline insulin secretion after Exercise intervention(12 weeks).

    Registry description

    By hyperglycemic clamp

  2. Insulin secretion

    Time frame · Change from baseline insulin secretion after 3 months of therapeutic semaglutide treatment

    Registry description

    By hyperglycemic clamp

  3. Insulin secretion

    Time frame · Change from baseline insulin secretion after 3 months of combined exercise and therapeutic semaglutide treatment

    Registry description

    By hyperglycemic clamp

Secondary outcomes(6)

  1. Insulin secretion

    Time frame · Before and after (3 days) Exercise intervention (12 weeks). Before and after 3 months of therapeutic semaglutide treatment

    Registry description

    By Oral glucose tolerance test

  2. insulin sensitivity

    Time frame · Before and after (2 days) Exercise intervention(12 weeks). Before and after 3 months of therapeutic semaglutide treatment

    Registry description

    Derived from hyperglycemic clamp and HOMA-IR

  3. Changes in plasma bone markers

    Time frame · Before and after (2 days) Exercise intervention (12 weeks). Before and after 3 months of therapeutic semaglutide treatment

    Registry description

    Changes in baseline CTX, PNIP, Osteocalcin and alkaline phosphatase

  4. Glucose homeostasis

    Time frame · Before and after (2 days) Exercise intervention (12 weeks). Before and after 3 months of therapeutic semaglutide treatment

    Registry description

    Changes in HbA1c

  5. Cardiorespiratory fitness

    Time frame · Before and after (3 days) Exercise intervention (12 weeks). Before and after 3 months of therapeutic semaglutide treatment

    Registry description

    Changes in maximal oxygen uptake

  6. Body composition

    Time frame · Before and after (3 days) Exercise intervention (12 weeks). Before and after 3 months of therapeutic semaglutide treatment

    Registry description

    By DXA

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2023

5 results

Effects of Aerobic Training and Semaglutide Treatment on Pancreatic β-Cell Secretory Function in Patients With Type 2 Diabetes.

Ingersen et al. 2023The Journal of clinical endocrinology and metabolismcited by 28

PMID 37265222DOI 10.1210/clinem/dgad326PUB-37265222

Full text at the publisher5 results
Publisher pageSee results (5)

Eligibility

Who could join, as posted.

Sex
All
Age
from 40 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Diagnosed with type 2 diabetes * BMI 28-35 * Moderately preserved insulin secretory capacity (determined by glucagon test) Exclusion Criteria: * Insulin treatment * Hypertension grade 3 * Heart disease * Medical history with pancreatitis * Diagnosed with neuropathy * Excessive alcohol consumption * Any condition that would interfere with the protocol.

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