High Intensity Interval Training and Skeletal Muscle Insulin Sensitivity

NCT03405545 | Completed DMC

• 1 other identifier: NL62654.068.17
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

This human intervention study will test if 12 weeks of supervised HIIT-based intervention improves skeletal muscle NOGD capacity in obese subjects.

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

• Non-oxidative glucose disposal

  Measured during a 2-step hyperinsulinemic-euglycemic clamp combined with indirect calorimetry

  9 hours

Secondary Outcomes (7)

• Skeletal muscle glycogen content

  1 hour

• Skeletal muscle insulin sensitivity

  9 hours

• 24 hour glycaemic profile

  48 hours

• Skeletal muscle mitochondrial function assessed by Magnetic Resonance Spectroscopy Scan using 31P-MRS methodology, based on the phosphocreatine (PCr) recovery kinetics after exercise.

  1 hour

• Metabolic Flexibility during exercise assessed by indirect calorimetry.

  30 minutes

Other Outcomes (1)

• Effect of consumption of insulinogenic, CHO-rich drink post-exercise

  12 weeks

Study Arms (1)

HIIT

EXPERIMENTAL

This group of subjects will perform High Intensity Interval training 3x/week for 12 weeks

Behavioral: High-intenstiy interval training

Interventions

High-intenstiy interval training BEHAVIORAL

High-intensity interval training is a training of 30 minutes involving 10 bouts of 1 minute high intensity cycling (80-90% of maximum heart rate) interspersed by 2 minutes rest.

HIIT

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• Age 45 - 75 years old
• Overweight to obese (BMI =\> 27kg/m2)
• Sedentary - subjects do not perform any regular physical activity weekly(\<3 times per week, \<150 min/week).

You may not qualify if:

• Unstable body weight (weight gain or loss \> 3 kg in the past three months)
• Participation in an intensive weight-loss program or in vigorous exercise program during the last year before starting the study.
• HbA1c \> 6.5% and glucose clearance rate \>350 ml/kg/min (by OGTT).
• Previously diagnosed with type 2 diabetes
• Active cardiovascular disease. This will be determined by the questionnaires and by screening on medication.
• Use of beta-blockers
• Anticoagulant therapy
• Systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mmHg
• Abuse of alcohol (\> 3 units (1 unit = 10 gr ethanol) per day)
• Any contra-indication to Magnetic Resonance Imaging (MRI) scanning
• Participation in another biomedical study within 1 month before the first study visit, which may interfere with the outcomes of the present study.
• Use of any medication affecting the glucose homeostasis and whole body metabolism or diseases that may significantly interfere with the main aim of the study.
• Chronic renal dysfunction (creatinine \>2 increased (normal value 64-104 µmol/l)
• Subjects who do not want to be informed about unexpected medical findings during the screening / study, or do not wish that their physician is informed, cannot participate in the study.
• Subjects will be included only when the dependent medical doctor of this study approves participation after evaluating all data obtained during the screening.

Sponsors & Collaborators

• Maastricht University: lead
• Netherlands Organisation for Scientific Research: collaborator

Study Sites (1)

University Maastricht

Maastricht, Limburg, 6229ER, Netherlands

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Matthijs Hesselink, Prof. PhD.

  Maastricht University

  PRINCIPAL INVESTIGATOR

• Vera Schrauwen-Hinderling, PhD

  Maastricht University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1 group of participants that performs 12 weeks of HIIT with metabolic measurements before and after this training period

Study Record Dates

• First Submitted: November 14, 2017
• First Posted: January 23, 2018
• Study Start: March 28, 2018
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: September 14, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)