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NCT03500016

Abnormalities in the Effects of Insulin and Exercise on Glucose- and Lipid Metabolism in Obesity and Type 2 Diabetes

Completed NA Last updated 2 September 2022
What this trial tests

NA trial testing High intensity interval training in Type2 Diabetes in 48 participants. Completed in 12 November 2021.

Timeline
26 February 2018
Primary endpoint
12 November 2021
12 November 2021

Quick facts

Lead sponsorOdense University Hospital
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposebasic science
Enrollment48
Start date26 February 2018
Primary completion12 November 2021
Estimated completion12 November 2021
Sites1 location across Denmark

Drugs / interventions tested

Conditions studied

Sponsor

Odense University Hospital

Who can join

Adults 40 to 65, male only, with Type2 Diabetes or Insulin Resistance. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Type 2 diabetes are characterized by insulin resistance in skeletal muscle. Insulin resistance plays a major role for the increased risk of heart disease seen in type 2 diabetes. No specific treatment of insulin resistance is currently available, except from increased physical activity and weight-loss. Insulin resistance is characterized by abnormalities in the use of glucose and fat in the muscle, and is associated with abnormal function and content of mitochondria (the power houses of our cells) as well as increased levels of fat within the muscle. The investigators believe that abnormalities in the use of glucose and fat in muscle cells in response to insulin and exercise can explain why insulin resistance is associated with abnormal function and content of mitochondria and an increased amount of fat in skeletal muscle of patients with type 2 diabetes and individuals with obesity. The major purpose of our project is, therefore, to investigate the effect of insulin in physiological concentrations and the effect of both acute exercise and 8 weeks of high intensity interval exercise-training on 1. insulin sensitivity, body composition, cardiorespiratory fitness and energy metabolism, 2. insulin signaling, mitochondrial dynamics and mitophagy in skeletal muscle 4\) regulators of storage of fat into lipid droplets and their interaction with mitochondria in skeletal muscle 5) acetylation and phosphorylation of enzymes (proteins) in major metabolic and signaling pathways, as well as 6) transcriptional and signalling networks regulating mitochondrial biogenesis and substrate metabolism. The effects of insulin in physiological concentrations and a novel exercise-intervention combining biking and rowing will be studied in a comprehensive study of obese patients with type 2 diabetes compared with weight-matched obese and lean healthy controls. The effects of insulin before and after 8 weeks HIIT on whole-body metabolism will be evaluated by measurement of maximal oxygen consumption, and well-known methods to determine insulin-stimulated glucose utilization, insulin secretion and use of glucose and fat. Skeletal muscle and fat tissue samples obtained under these conditions will be used for assessment of tissue-levels of specific sets of genes and enzymes known to be involved in insulin action, quality and size of mitochondria, and storage of fat into lipid droplets and their interaction with mitochondria. This project is expected to provide important and novel insight into the causal relationship between insulin resistance, accumulation of fat and abnormal content and function of mitochondria in skeletal muscle in type 2 diabetes. The investigators ultimately expect that our findings will help us to identify novel molecules or enzymatic pathways, which can be used to develop drugs that can enhance or mimic the effects of insulin and exercise, and hence be used in the prevention and treatment of type 2 diabetes and heart disease.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. High-throughput proteomics uncovers exercise training and type 2 diabetes-induced changes in human white adipose tissue.
    Larsen JK, Kruse R, Sahebekhtiari N, Moreno-Justicia R, et al · · 2023 · cited 20× · PMID 38019916 · DOI 10.1126/sciadv.adi7548
  2. The mitochondrial mRNA-stabilizing protein SLIRP regulates skeletal muscle mitochondrial structure and respiration by exercise-recoverable mechanisms.
    Pham TCP, Raun SH, Havula E, Henriquez-Olguín C, et al · · 2024 · cited 16× · PMID 39537626 · DOI 10.1038/s41467-024-54183-4
  3. High-intensity interval training combining rowing and cycling improves but does not restore beta-cell function in type 2 diabetes.
    Houborg Petersen M, Stidsen JV, Eisemann de Almeida M, Kleis Wentorf E, et al · · 2024 · cited 1× · PMID 38513367 · DOI 10.1530/ec-23-0558
  4. Plasma Proteomics Identifies Insulin Resistance Signatures Predictive of Cardiometabolic Disease Risk
    Northcote* JK, Kurgan* N, Gräf JF, Custódio MDC, et al · · 2026 · DOI 10.21203/rs.3.rs-8585654/v1

Verify or expand the search:

Other trials of High intensity interval training

Trials testing the same drug.

Other recruiting trials for Type2 Diabetes

Currently open trials in the same condition.

Other Odense University Hospital trials

Trials by the same sponsor.

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