NCT07829042

Brief Summary

This study will be conducted as a prospective, randomized crossover trial evaluating non-diabetic and pre-diabetic adults ($n=12$) continuously monitored with Dexcom G7 continuous glucose monitors over an 11-day period. Participants will complete two distinct exercise protocols in a randomized sequence: five consecutive days of Zone 2 aerobic exercise and a single session of high-intensity interval training (HIIT). Primary outcome metrics will focus on mean glucose levels and time in range (TIR, defined as $\\le 120\\text{ mg/dL}$) recorded throughout each active exercise block and its associated recovery window. To evaluate the comparative efficacy of the two modalities, paired within-subject differences will be statistically analyzed against pre-specified non-inferiority margins set at $3\\text{ mg/dL}$ for mean glucose, as well as a primary $3$-point and secondary $5$-point margin for time in range.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
0mo left

Started Sep 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress55%
Sep 2026Oct 2026

First Submitted

Initial submission to the registry

September 2, 2026

Completed
13 days until next milestone

Study Start

First participant enrolled

September 15, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 18, 2026

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2026

Expected
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2026

Last Updated

September 22, 2026

Status Verified

September 1, 2026

Enrollment Period

1 month

First QC Date

September 2, 2026

Last Update Submit

September 18, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Mean Glucose Concentration

    Average glucose level recorded by continuous glucose monitor (CGM) across the exercise intervention block and its subsequent recovery window.

    Measured continuously over each 5-day exercise/recovery block within the 11-day monitoring period.

  • Time in Range (TIR)

    Percentage of time spent with sensor glucose values under 120mg/dL during the active exercise block and its recovery window.

    Measured continuously over each 5-day exercise/recovery block within the 11-day monitoring period.

Study Arms (2)

Moderate Intensity Exercise

EXPERIMENTAL

Five consecutive days of moderate intensity aerobic exercise

Other: Moderate Intensity aerobic training

High Intensity Exercise

ACTIVE COMPARATOR

One session High-Intensity Interval training

Other: High Intensity Interval Training

Interventions

The Norwegian 4x4: The workout begins with a 5-to-10-minute warm-up, followed by four separate 4-minute high-intensity intervals where you push your body to 85%-95% of your maximum heart rate (roughly an 8 or 9 out of 10 effort level, where you are breathing too heavily to speak full sentences). Each intense "push" is interspersed with a 3-minute active recovery period of low-intensity movement-such as walking or light cycling-to let your heart rate drop back down to roughly 60%-70% of its maximum before starting the next round.

High Intensity Exercise

45 minutes of zone 2 training for five consecutive days

Moderate Intensity Exercise

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years or older Non-diabetic or pre-diabetic status (defined by medical history or standard screening criteria, e.g., HbA1c \< 6.5%) Capable and willing to participate in both Zone 2 aerobic exercise and high-intensity interval training (HIIT) protocols Willing to wear a continuous glucose monitor (Dexcom G7) continuously for the 11-day study duration Able to provide written informed consent

You may not qualify if:

  • Diagnosis of Type 1 or Type 2 diabetes Use of glucose-lowering medications, insulin, or other pharmaceuticals that significantly alter glucose metabolism Current skin conditions, allergies, or sensitivities to medical-grade adhesives that prevent continuous glucose monitor placement Musculoskeletal, cardiovascular, or neurological conditions that contraindicate vigorous exercise or high-intensity interval training Pregnant or planning to become pregnant during the study period Concurrent participation in another clinical trial or interventional exercise study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (5)

  • Dent JR, Stocks B, Campelj DG, Philp A. Transient changes to metabolic homeostasis initiate mitochondrial adaptation to endurance exercise. Semin Cell Dev Biol. 2023 Jul 15;143:3-16. doi: 10.1016/j.semcdb.2022.03.022. Epub 2022 Mar 26.

    PMID: 35351374BACKGROUND
  • Cartee GD. Mechanisms for greater insulin-stimulated glucose uptake in normal and insulin-resistant skeletal muscle after acute exercise. Am J Physiol Endocrinol Metab. 2015 Dec 15;309(12):E949-59. doi: 10.1152/ajpendo.00416.2015. Epub 2015 Oct 20.

    PMID: 26487009BACKGROUND
  • Colberg SR, Sigal RJ, Yardley JE, Riddell MC, Dunstan DW, Dempsey PC, Horton ES, Castorino K, Tate DF. Physical Activity/Exercise and Diabetes: A Position Statement of the American Diabetes Association. Diabetes Care. 2016 Nov;39(11):2065-2079. doi: 10.2337/dc16-1728. No abstract available.

    PMID: 27926890BACKGROUND
  • Tucker WJ, Fegers-Wustrow I, Halle M, Haykowsky MJ, Chung EH, Kovacic JC. Exercise for Primary and Secondary Prevention of Cardiovascular Disease: JACC Focus Seminar 1/4. J Am Coll Cardiol. 2022 Sep 13;80(11):1091-1106. doi: 10.1016/j.jacc.2022.07.004.

    PMID: 36075680BACKGROUND
  • Wei J, Shen M, Li S, Xiao Y, Luo D, Ferrari G, Lee DH, Rezende LFM, Gill JMR, Ahmadi MN, Stamatakis E, Chen X. Volume vs intensity of physical activity and risk of cardiovascular and non-cardiovascular chronic diseases. Eur Heart J. 2026 Mar 29:ehag168. doi: 10.1093/eurheartj/ehag168. Online ahead of print.

    PMID: 41905344BACKGROUND

Related Links

MeSH Terms

Interventions

High-Intensity Interval Training

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jeanne Noble, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeanne Noble, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2026

First Posted

September 18, 2026

Study Start

September 15, 2026

Primary Completion (Estimated)

October 15, 2026

Study Completion (Estimated)

October 20, 2026

Last Updated

September 22, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations