Type 2 DiabetesT2D-HIITNCT06688461
High Intensity Interval Training and Insulin Sensitivity in Type 2 Diabetes
A study testing Experimental group: Exercise training in people with Type 2 Diabetes and Lifestyle-related Condition, run by Finis Terrae University at 1 site in Chile.
Trial summary
A recognized driver for cardiovascular complications of type 2 diabetes mellitus (T2DM) is impaired plasma glucose homeostasis as consequence of skeletal muscle insulin resistance. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Type 2 Diabetes, Lifestyle-related Condition, Insulin Sensitivity/Resistance
- What is being tested?
- Experimental group: Exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChile
- Study dates
- 1 Oct 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants are able to provide signed and dated written informed consent prior to any study specific procedures
- Aged ≥ 45 and ≤ 75 years
- BMI: 25-35 kg/m2
- Diagnosed as T2DM patients for at least 1 year and not longer than 5 years
- HbA1c ≥ 6.5% and ≤ 8.5%
- Fasting blood glucose <130 mg/dL
- Women are post-menopausal (>1 year cessation of menses),
- Being stable on medication use of metformin and/or sulfonylurea derivatives for the previous 3 months or more and other medication naïve.
Who cannot join
- Type 1 diabetes
- Patients with congestive heart failure and and/or severe renal and or liver insufficiency
- Contraindications for MRI/MRS examination
- Active diabetic foot
- Polyneuropathy or retinopathy
- Signs of active liver or kidney dysfunction
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- BMI >35 kg/m2
- Exogeneous insulin therapy
- Use of antidiabetic medication other than metformin or sulfonylurea derivatives treatment within 3 months before screening
- Use of SGLT2 inhibitors
- Unstable body weight (variations >5kg in the last 3 months)
- Ongoing weight loss diet or use of weight loss agents
- Uncontrolled hypertension
- Engagement in regular exercise program or any other medical condition that will impede the safe performance of the experiments
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chile1 site, 1 recruiting
- Recruiting
Finis Terrae University
Santiago
Rodrigo Mancilla, PhD
About this study
Official title: Effects of High Intensity Interval Training on Skeletal Muscle Insulin Sensitivity in Type 2 Diabetes Patients
A recognized driver for cardiovascular complications of type 2 diabetes mellitus (T2DM) is impaired plasma glucose homeostasis as consequence of skeletal muscle insulin resistance. Insulin-mediated plasma glucose disposal in skeletal muscle comprises oxidative glucose disposal (cellular glucose uptake for oxidation) and non-oxidative glucose disposal (NOGD; cellular glucose uptake for storage as glycogen), both processes being impaired in T2DM patients. Excessive intrahepatic fat accumulation (particularly monounsaturated (MUFA) and saturated (SFA)) is commonly observed in T2DM patients and tightly associates with plasma glucose dysregulation. It has been hypothesized that skeletal muscle insulin resistance redistributes circulating glucose away from muscle which together with hyperinsulinemia promotes intrahepatic lipid accretion via de novo lipogenesis (DNL). As saturated lipids is the final product of DNL, improving skeletal muscle insulin sensitivity, next to enhance plasma glucose homeostasis, might lower intrahepatic lipid content particularly intrahepatic saturated lipids.
Regular exercise is a cornerstone in the treatment of T2DM and to improve skeletal muscle insulin sensitivity. Interestingly, a conventional exercise program (aerobic-type combined with strength-type exercise) restores insulin-stimulated oxidative glucose disposal in T2DM patients to levels observed in age-matched normoglycemic subjects. Non-oxidative glucose disposal (NOGD), however, does not improve upon such conventional exercise programs. In this regard, for full restoration of compromised glucose disposal, it is pivotal to come up with effective training methods to target NOGD. High intensity interval training (HIIT) has the potential to expands the glycogen synthesis capacity in athletes by repetitive cycles of glycogen depletion/repletion, hence holds promise to improve NOGD in T2DM patients. Of note, HIIT also lowers the intrahepatic fat content in pre-diabetes individuals. Nevertheless, whether HIIT reduces the intrahepatic fat content and modifies its composition in T2DM patients is unknown. In this regard, it is hypothesized that HIIT expands the NOGD capacity in skeletal muscle of overweight/obese type 2 diabetes patients. By doing so, it is postulated that HIIT improves skeletal muscle insulin sensitivity and therefore benefits the 24 hours glycaemic profile in T2DM patients. In line, it is hypothesized that the HIIT-mediated improvements on NOGD and skeletal muscle insulin sensitivity coexist with the reduction of intrahepatic lipid content -particularly reduced saturated lipids- via lowering DNL.
- Being tested
- Experimental group: Exercise training
- Medical subject headings
- Diabetes Mellitus, Type 2, Mental Disorders, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental group: Exercise trainingOther
HIIT program, 3 times per week for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| T2D-HIIT | Experimental | This arm will perform HIIT under supervision. The post training condition of this arm will be compared to an age and BMI matched, normoglycemic non-intervention group. Receives: Other: Experimental group: Exercise training |
| T2D-CON | No intervention | This corresponds to a non-training, control group, of age-, BMI matched, type 2 diabetes individuals. |
| NORM | No intervention | A group of normoglycemic individuals will the reference comparison for the T2D-HIIT arm post-intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin-stimulated non-oxidative plasma glucose disposal (NOGD)
Insulin-stimulated NOGD will be measured upon hyperinsulinemic-euglycemic clamp test
Measured: 12 weeks
Secondary outcomes (1)
Skeletal muscle insulin sensitivity
Skeletal muscle insulin sensitivity will be measured as the rate of insulin-stimulated plasma glucose disposal (Rd) measured upon hyperinsulinemic-euglycemic clamp test
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start1 Oct 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1 interventional group of type 2 diabetes participants will undergo the 12-weeks of the HIIT program. 1 non-intervention control group of, age- and BMI matched type 2 diabetes participants. 1 non-interventional group of, age- and BMI matched, normoglycemic individuals will be the reference comparison for the post-training condition.
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Finis Terrae University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodrigo Mancilla, Finis Terrae University
- Investigators
- Rodrigo Mancilla, PhD, Principal investigator, Finis Terrae University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06688461
- Sponsor's protocol ID
- 24-001
- Acronym
- T2D-HIIT
- Status last verified
- Mar 2026
- First submitted
- 11 Nov 2024
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High Intensity Interval Training on Skeletal Muscle Insulin Sensitivity in Type 2 Diabetes Patients
- ClinicalTrials.gov ID
- NCT06688461
- Acronym / sponsor ID
- T2D-HIIT / 24-001
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Finis Terrae UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A recognized driver for cardiovascular complications of type 2 diabetes mellitus (T2DM) is impaired plasma glucose homeostasis as consequence of skeletal muscle insulin resistance. Insulin-mediated plasma glucose disposal in skeletal muscle comprises oxidative glucose disposal (cellular glucose uptake for oxidation) and non-oxidative glucose disposal (NOGD; cellular glucose uptake for storage as glycogen), both processes being impaired in T2DM patients. Excessive intrahepatic fat accumulation (particularly monounsaturated (MUFA) and saturated (SFA)) is commonly observed in T2DM patients and tightly associates with plasma glucose dysregulation. It has been hypothesized that skeletal muscle insulin resistance redistributes circulating glucose away from muscle which together with hyperinsulinemia promotes intrahepatic lipid accretion via de novo lipogenesis (DNL). As saturated lipids is the final product of DNL, improving skeletal muscle insulin sensitivity, next to enhance plasma glucose homeostasis, might lower intrahepatic lipid content particularly intrahepatic saturated lipids.
Regular exercise is a cornerstone in the treatment of T2DM and to improve skeletal muscle insulin sensitivity. Interestingly, a conventional exercise program (aerobic-type combined with strength-type exercise) restores insulin-stimulated oxidative glucose disposal in T2DM patients to levels observed in age-matched normoglycemic subjects. Non-oxidative glucose disposal (NOGD), however, does not improve upon such conventional exercise programs. In this regard, for full restoration of compromised glucose disposal, it is pivotal to come up with effective training methods to target NOGD. High intensity interval training (HIIT) has the potential to expands the glycogen synthesis capacity in athletes by repetitive cycles of glycogen depletion/repletion, hence holds promise to improve NOGD in T2DM patients. Of note, HIIT also lowers the intrahepatic fat content in pre-diabetes individuals. Nevertheless, whether HIIT reduces the intrahepatic fat content and modifies its composition in T2DM patients is unknown. In this regard, it is hypothesized that HIIT expands the NOGD capacity in skeletal muscle of overweight/obese type 2 diabetes patients. By doing so, it is postulated that HIIT improves skeletal muscle insulin sensitivity and therefore benefits the 24 hours glycaemic profile in T2DM patients. In line, it is hypothesized that the HIIT-mediated improvements on NOGD and skeletal muscle insulin sensitivity coexist with the reduction of intrahepatic lipid content -particularly reduced saturated lipids- via lowering DNL.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 1 interventional group of type 2 diabetes participants will undergo the 12-weeks of the HIIT program. 1 non-intervention control group of, age- and BMI matched type 2 diabetes participants. 1 non-interventional group of, age- and BMI matched, normoglycemic individuals will be the reference comparison for the post-training condition.
| Arm | Type | Receives |
|---|---|---|
| T2D-HIIT | Experimental | Other: Experimental group: Exercise trainingThis arm will perform HIIT under supervision. The post training condition of this arm will be compared to an age and BMI matched, normoglycemic non-intervention group. |
| T2D-CON | No intervention | –This corresponds to a non-training, control group, of age-, BMI matched, type 2 diabetes individuals. |
| NORM | No intervention | –A group of normoglycemic individuals will the reference comparison for the T2D-HIIT arm post-intervention |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants are able to provide signed and dated written informed consent prior to any study specific procedures
- Aged ≥ 45 and ≤ 75 years
- BMI: 25-35 kg/m2
- Diagnosed as T2DM patients for at least 1 year and not longer than 5 years
- HbA1c ≥ 6.5% and ≤ 8.5%
Key exclusion criteria (14 listed)
- Type 1 diabetes
- Patients with congestive heart failure and and/or severe renal and or liver insufficiency
- Contraindications for MRI/MRS examination
- Active diabetic foot
- Polyneuropathy or retinopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental group: Exercise trainingHIIT program, 3 times per week for 12 weeks | Other | T2D-HIIT |
Primary outcome
Insulin-stimulated non-oxidative plasma glucose disposal (NOGD)
Time frame: 12 weeks
Insulin-stimulated NOGD will be measured upon hyperinsulinemic-euglycemic clamp test
1 secondary outcome
Skeletal muscle insulin sensitivity
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rodrigo Mancilla, PhD principal investigator
Finis Terrae University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group: Exercise training in people with Type 2 Diabetes and Lifestyle-related Condition, run by Finis Terrae University at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rodrigo Mancilla, PhD (+56953676588, rmancilla@uft.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin-stimulated non-oxidative plasma glucose disposal (NOGD) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.