NCT02196623

Brief Summary

Ageing is the primary risk factor for most chronic diseases including type 2 diabetes mellitus. Sarcopenia and muscular mitochondrial dysfunction with aging are crucial mechanisms leading to decreased exercise tolerance and worsened insulin sensitivity. Thus, metabolic disease and frailty, which limits physical mobility as well as quality of life, share common cellular mechanisms. The investigators will test the hypothesis that a combination of normobaric hypoxia and exercise training elicits a synergistic effect on age-associated metabolic skeletal muscle dysfunction and the investigators will address the molecular mechanisms. In a randomized clinical study, the investigators will compare normoxic and hypoxic training conditions in elderly subjects. Outcome measures will focus on whole body insulin sensitivity and mitochondrial responses in skeletal muscle before and after the 8-week training intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 22, 2014

Completed
10 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

June 29, 2025

Status Verified

August 1, 2017

Enrollment Period

2.3 years

First QC Date

July 18, 2014

Last Update Submit

June 26, 2025

Conditions

Elderly Persons

Outcome Measures

Primary Outcomes (1)

  • Insulin sensitivity

    Insulin sensitivity is assessed via the hyperinsulinemic euglycemic glucose clamp and expressed as the glucose infusion rate (GIR) in ml

    At baseline and after 8 weeks

Secondary Outcomes (5)

  • Maximum oxygen uptake

    At baseline and after 8 weeks

  • Mitochondrial number

    At baseline and after 8 weeks

  • Fat and carbohydrate oxidation during exercise

    At baseline and after 8 weeks

  • Body fat and body fat free mass

    At baseline and after 8 weeks

  • Health related quality of life

    At baseline and after 8 weeks

Study Arms (2)

Hypoxic Exercise

EXPERIMENTAL

Supervised, progressive aerobic exercise for 8 weeks under hypoxic conditions

Other: Hypoxic exercise

Normoxic exercise

SHAM COMPARATOR

Supervised, progressive aerobic exercise for 8 weeks under normoxic conditions

Other: Normoxic Exercise

Interventions

Hypoxic exerciseOTHER

Supervised, progressive aerobic exercise program for 8 weeks under hypoxic conditions

Hypoxic Exercise
Normoxic ExerciseOTHER

Supervised, progressive aerobic exercise program for 8 weeks under normoxic conditions

Normoxic exercise

Eligibility Criteria

Age55 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 75 years of age
  • body mass index: 20 - 35 kg/m2
  • weight stable during last 6 months before screening (weight change \< 2% body weight)
  • HOMA-index of insulin resistance ≥ 2 to 4 units

You may not qualify if:

  • more than 1 hour of scheduled exercise training per week
  • known diagnosis of type 2 diabetes or measured HbA1c \> 6,5%
  • known drug or alcohol abuse
  • any contraindication to perform exercise training
  • acute or chronic infections
  • increased bleeding risk by history, INR \> 1,3, use of anticoagulants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hannover Medical School

Hanover, Lower Saxony, 30625, Germany

Location

Related Publications (2)

  • Hein M, Chobanyan-Jurgens K, Tegtbur U, Engeli S, Jordan J, Haufe S. Effect of normobaric hypoxic exercise on blood pressure in old individuals. Eur J Appl Physiol. 2021 Mar;121(3):817-825. doi: 10.1007/s00421-020-04572-6. Epub 2020 Dec 23.

    PMID: 33355713BACKGROUND

  • Chobanyan-Jurgens K, Scheibe RJ, Potthast AB, Hein M, Smith A, Freund R, Tegtbur U, Das AM, Engeli S, Jordan J, Haufe S. Influences of Hypoxia Exercise on Whole-Body Insulin Sensitivity and Oxidative Metabolism in Older Individuals. J Clin Endocrinol Metab. 2019 Nov 1;104(11):5238-5248. doi: 10.1210/jc.2019-00411.

    PMID: 30942862BACKGROUND

Study Officials

  • Sven Haufe, Dr.

    Hannover Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2014

First Posted

July 22, 2014

Study Start

June 1, 2015

Primary Completion

September 1, 2017

Study Completion

January 1, 2019

Last Updated

June 29, 2025

Record last verified: 2017-08

Locations

DE(1)