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High Intensity Interval Training and Insulin Sensitivity in Type 2 Diabetes

Not Applicable
Recruiting
Conditions
Type 2 Diabetes
Lifestyle-related Condition
Insulin Sensitivity/Resistance
Registration Number
NCT06688461
Lead Sponsor
Finis Terrae University
Brief 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. 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
15
Inclusion Criteria
  • 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.
Exclusion Criteria
  • 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
  • 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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Insulin-stimulated non-oxidative plasma glucose disposal (NOGD)12 weeks

Insulin-stimulated NOGD will be measured upon hyperinsulinemic-euglycemic clamp test

Secondary Outcome Measures
NameTimeMethod
Metabolic flexibility12 weeks

Metabolic flexibility will be measured via indirect calorimetry during the clamp test

Total fat mass12 weeks

Total fat mass will be measured in kilograms and/or percentage

Fat-free mass12 weeks

Fat-free mass will be measured in kilograms and/or percentage

Skeletal muscle insulin sensitivity12 weeks

Skeletal muscle insulin sensitivity will be measured as the rate of insulin-stimulated plasma glucose disposal (Rd) measured upon hyperinsulinemic-euglycemic clamp test

Insulin-stimulated glucose oxidation12 weeks

Insulin-stimulated glucose oxidation will be measured via indirect calorimetry during clamp test

Liver insulin sensitivity12 weeks

Liver insulin sensitivity will be measured as the rate of insulin-mediated suppression of endogenous glucose production (EGP) upon hyperinsulinemic-euglycemic clamp test

Intrahepatic lipid content and composition12 weeks

Intrahepatic lipid content and composition will be measured by magnetic resonance spectroscopy of protons (1H-MRS)

De novo lipogenesis (DNL)12 weeks

DNL will be measured by the use of deuterated water (D2O)

24 hours glycemic profile12 weeks

24 hours glycemic profile will be measured by the use of continuous glucose monitoring device

Skeletal muscle glycogen content12 weeks

Muscle glycogen content will be quantified in muscle biopsies

Proteins that regulate oxidative metabolism12 weeks

Content of proteins that regulate oxidative phosphorylation system (OXPHOS) will be quantified in muscle biopsies

Maximal aerobic capacity12 weeks

Maximal aerobic capacity will be measure upon a progressive cycling test

Body weight12 weeks

Body weight will be measured in kilograms

Total muscle mass12 weeks

total muscle mass will be measured in kilograms and/or percentage

Trial Locations

Locations (1)

Finis Terrae University

🇨🇱

Santiago, Chile

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