ClinicalTrials.gg
CompletedNCT04222231RESISTUpdated Nov 5, 2026

RESIST! Blood-flow Restriction Resistance Training for Improving Insulin Sensitivity in Type 2 Diabetes

An interventional study of Blood-flow restriction resistance training and Classical resistance training in Type 2 Diabetes, sponsored by German Diabetes Center. Completed at 1 site in Germany. Open to participants aged 30 Years to 69 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by German Diabetes Center · Not applicable, Interventional, and Basic science

Updated Nov 5, 2026Now CompletedPrimary completion moved+4 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
30 Years to 69 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 16 studies in Diabetes Mellitus, Type 2 by German Diabetes Center — 3 open to participants now, 4 under way, none of them phase 3. Diabetes Mellitus, Type 2 · German Diabetes Center.

Enrollment
11th of 13
20 · median 24
Started
2019
with 1 other
No phase
11 of 16
1 open now
Registered
14th of 16
by date

Among the 16 studies in Diabetes Mellitus, Type 2 by German Diabetes Center, this one is the 11th largest by enrollment of the 13 interventional ones that give a count, is one of 2 that started in 2019, is one of 11 with no phase, and was the 14th registered.

Diabetes Mellitus, Type 2

10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.

This study's enrollment of 20 is below the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Open to participants now

3 of the 16 studies in Diabetes Mellitus, Type 2 by German Diabetes Center are open now, in 1 country. Each count lists the studies.

All 3 open studies →

Where they have run

Who these studies take

Of the 883 Diabetes Mellitus, Type 2 studies recruiting now, 373 (42%) set no upper age limit and 384 (43%) stop at 75 or younger; 52 take children under 18; 203 take healthy volunteers.

This study: 30 Years to 69 Years · all sexes · healthy volunteers too.

The full table on the hub →
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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 16 studies in Diabetes Mellitus, Type 2 by German Diabetes Center, or all of them as a file.
02

Study summary

The study aims to investigate the metabolic and cardiovascular effects of classical resistance training with high loads and blood-flow restricted training (BFRT) with low loads in individuals with type 2 diabetes over 12 weeks.

Read the detailed description

Type 2 diabetes (T2D) is characterized by an increasing insensitivity of muscle, fat and liver cells to the hormone insulin. About 9% of the global population is affected by this condition and mortality risk is twice as high in individuals with diabetes compared to similar-aged people without diabetes.

Muscle is of particular importance for glucose homeostasis, since in healthy people it accounts for 80-90% of postprandial insulin-stimulated glucose disposal. After cellular uptake of glucose by the specialized glucose transporter 4 (GLUT4), glucose is phosphorylated and stored as glycogen. In individuals with obesity or T2D, the capacity for insulin to facilitate glucose uptake and glycogen synthesis is impaired. This reduced response of a given insulin concentration to exert its biological effect is termed insulin resistance. Subsequent diminished insulin secretion due to β-cell failure results in fasting hyperglycemia and overt diabetes. Importantly, muscle insulin resistance is the initial defect occurring in the development of T2D and precedes the clinical development of the disease by up to 20 years.

Thus, the preservation of skeletal muscle function is essential for people with T2D who have an increased risk of sarcopenia. On the one hand high intensity resistance training (HIT) with 80 % one-repetition maximum (%1-RM) is a well-recognized strategy to improve muscle strength and glycemic control for individuals with T2D, on the other hand elderly or obese people may not be able to tolerate these high loads. Blood flow restriction training (BFRT) with low loads (20-30% 1-RM) has consistently demonstrated comparable effects to HIT and seems to be a promising alternative to increase muscle function.

During the BFRT the muscle becomes hypoxic due to a brief occlusion of venous blood flow using a tourniquet while exercising. Consequently metabolites like lactate, growth hormone (GH) and insulin like growth factor (IGF-1) are released and result in muscle hypertrophy through activating the collagen synthesis and the recruitment of satellite cells. Furthermore cell swelling based on venous blood pooling, reactive hyperemia and metabolite accumulation has been shown to increase protein synthesis by activating the mammalian Target of Rapamycin Complex 1 (mTORC1) pathway. Also, BFRT increases the level of reactive oxygen species (ROS) which may lead to higher glucose uptake during exercise. Last but not least higher threshold motor units (fast twitch fibers) are recruited due to hypoxia and metabolite accumulation.

Although there is a significant inverse relationship between muscle strength and the risk of cardiovascular mortality, cardiovascular adaptations to resistance training are under-explored and poorly understood.

The study therefore aims to investigate the metabolic and cardiovascular effects of BFRT with low loads in individuals with T2D.

03

Conditions studied

  • Type 2 Diabetes

Keywords

  • Insulin sensitivity
  • Blood flow restriction training
  • Muscle hypertrophy
  • Muscle Strength
  • Hypoxia
04

Who can participate

Ages eligible
30 Years to 69 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male and female, age between ≥ 30 and ≤ 69 years
  • Individuals with type 2 diabetes
  • : 19-40 kg/m²

Exclusion criteria

Exclusion Criteria:

  • Acute infections in the last 2 weeks
  • Weight fluctuations (> 10% in the last 6 month)
  • Therapy with Glitazone, Beta blocker, Insulin
  • Malignant cancer
  • Heart diseases (angina pectoris, myocardial infarction, acute myocarditis or pericarditis, cardiac wall aneurysms/ stenose, untreated hypotension or hypertension, aortic stenosis, stroke, cardiac insufficiency, -class ≥II, heart arrhythmia, disturbances of blood circulation in extremities, venous insufficiency, varicose veins)
  • Diabetic neuropathy
  • Respiratory disease (, Gold grade ≥II)
  • Serious heart, kidney or liver disease: - New York Heart Association-Classification (NYHA) stage ≥ II - creatinine ≥ 1.6 mg / dl - (AST) or Alanine Aminotransferase (ALT) ≥ two-fold upper reference value
  • Anemia ( \<12g / l), blood donation in the last 3 month
  • Disease of the immune system (leucocytes \<5000/μl)
  • Application of immunomodulatory agents (, Antihistamine, Acetylsalicylic acid)
  • Application of antithrombotic agents (Anticoagulant)
  • Blood clotting disorders (abnormally levels of [\<150.000, >450.000 ± 50 ], (PTT) [26-36 s ± 5 s], Quick [70-120% ± 10%]) or wound healing
  • Thyroid disease (untreated hypothyroidism or hyperthyroidism, treatment with thiamazol)
  • Epilepsy
  • Application of drugs which can manipulate the thermoregulation (Antipsychotic)
  • Rosacea
  • Vitamine supplement (with the las 4 weeks)
  • Cigarettes (or non-smokers \<1 year) alcohol consumption (men> 30 g / d, women> 20 g / d), drug abuse
  • Severe psychiatric illness or addiction
  • Risk for/ or or or C
  • Shift work or anormal circadian rhythm
  • Muscle diseases, orthopedic restrictions
  • to local anaesthetic
  • Pregnancy, lactation
  • Metallic and magnetic implants (for example, mechanical heart valves, joint prostheses, clip after vascular surgery, middle and inner ear implants or fresh dental implants)
  • Claustrophobia
  • Hypohidrosis
  • Participation in another intervention study within the last 3 month
Terms in these criteria, in plain language(11)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Blood-flow restriction resistance training

    Resistance training with low loads (15-30% RM) in combination with a brief occlusion of venous blood flow using a tourniquet while exercising.

    Other: Blood-flow restriction resistance training

  • Experimental
    Classical resistance training

    Resistance training with high loads (60-80% RM).

    Other: Classical resistance training

Interventions

  • OtherBlood-flow restriction resistance training

    Training program: After 10 minutes of warm-up the participant performs three exercises with BFRT for the lower extremities. The intensity is about 15-30% of 1-RM.

  • OtherClassical resistance training

    Training program: After warm-up the participant performs three exercises for lower body. The intensity is about 60-80% of 1-RM.

06

What researchers measure

Primary outcomes

  1. Change in insulin sensitivity by blood-flow restriction or classical resistance training

    By using hyperinsulinemic-euglycemic clamp technique, changes in the M-value (mg x kg-1 x min-1) will be measured. The m-value represent the glucose infusion rate at a defined level of hyperinsulinemia during a glucose clamp test. The hyperinsulinemic-euglycemic clamp technique will thus be implicated to assess changes in insulin sensitivity before and after 12 weeks of resistance training.

    Time frame: Before and after 12 weeks of training (intervention)

Secondary outcomes

  1. Changes in skeletal muscle mass by blood-flow restriction or classical resistance training

    Cross-sectional area (cm2) from quadriceps will be measured by MRI imaging technique to evaluate changes in muscle diameter ("hypertrophy") before and after 12 weeks of resistance training.

    Time frame: Before and after 12 weeks of training (intervention)

Other outcomes

  1. Changes in skeletal muscle strength by blood-flow restriction or classical resistance training

    Isometric and submaximal strength tests (kg) will be performed to measure changes in muscle strength before and after 12 weeks of resistance training.

    Time frame: Before and after 12 weeks of training (intervention)

07

Study locations

1 site
08

References and documents

Publications

  • Christiansen D, Eibye KH, Hostrup M, Bangsbo J. Blood flow-restricted training enhances thigh glucose uptake during exercise and muscle antioxidant function in humans. Metabolism. 2019 Sep;98:1-15. doi: 10.1016/j.metabol.2019.06.003. Epub 2019 Jun 12. PubMed 31199953 ↗
  • Loenneke JP, Fahs CA, Rossow LM, Abe T, Bemben MG. The anabolic benefits of venous blood flow restriction training may be induced by muscle cell swelling. Med Hypotheses. 2012 Jan;78(1):151-4. doi: 10.1016/j.mehy.2011.10.014. Epub 2011 Nov 1. PubMed 22051111 ↗
  • Abe T, Fujita S, Nakajima T, Sakamaki M, Ozaki H, Ogasawara R, Sugaya M, Kudo M, Kurano M, Yasuda T, Sato Y, Ohshima H, Mukai C, Ishii N. Effects of Low-Intensity Cycle Training with Restricted Leg Blood Flow on Thigh Muscle Volume and VO2MAX in Young Men. J Sports Sci Med. 2010 Sep 1;9(3):452-8. eCollection 2010. PubMed 24149640 ↗
  • Takarada Y, Takazawa H, Sato Y, Takebayashi S, Tanaka Y, Ishii N. Effects of resistance exercise combined with moderate vascular occlusion on muscular function in humans. J Appl Physiol (1985). 2000 Jun;88(6):2097-106. doi: 10.1152/jappl.2000.88.6.2097. PubMed 10846023 ↗
  • Takarada Y, Nakamura Y, Aruga S, Onda T, Miyazaki S, Ishii N. Rapid increase in plasma growth hormone after low-intensity resistance exercise with vascular occlusion. J Appl Physiol (1985). 2000 Jan;88(1):61-5. doi: 10.1152/jappl.2000.88.1.61. PubMed 10642363 ↗
  • Hughes L, Paton B, Rosenblatt B, Gissane C, Patterson SD. Blood flow restriction training in clinical musculoskeletal rehabilitation: a systematic review and meta-analysis. Br J Sports Med. 2017 Jul;51(13):1003-1011. doi: 10.1136/bjsports-2016-097071. Epub 2017 Mar 4. PubMed 28259850 ↗
  • Mattocks KT, Jessee MB, Mouser JG, Dankel SJ, Buckner SL, Bell ZW, Owens JG, Abe T, Loenneke JP. The Application of Blood Flow Restriction: Lessons From the Laboratory. Curr Sports Med Rep. 2018 Apr;17(4):129-134. doi: 10.1249/JSR.0000000000000473. PubMed 29629973 ↗
  • Harreiter J, Roden M. [Diabetes mellitus-Definition, classification, diagnosis, screening and prevention (Update 2019)]. Wien Klin Wochenschr. 2019 May;131(Suppl 1):6-15. doi: 10.1007/s00508-019-1450-4. German. PubMed 30980151 ↗
  • Pesta DH, Goncalves RLS, Madiraju AK, Strasser B, Sparks LM. Resistance training to improve type 2 diabetes: working toward a prescription for the future. Nutr Metab (Lond). 2017 Mar 2;14:24. doi: 10.1186/s12986-017-0173-7. eCollection 2017. PubMed 28270856 ↗
  • Centner C, Wiegel P, Gollhofer A, Konig D. Effects of Blood Flow Restriction Training on Muscular Strength and Hypertrophy in Older Individuals: A Systematic Review and Meta-Analysis. Sports Med. 2019 Jan;49(1):95-108. doi: 10.1007/s40279-018-0994-1. PubMed 30306467 ↗

Related links

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2019 to primary completion in May 2024, 54 months.

Of 2,066 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's 54 months is above that.

Counting every sponsor, half of 2,243 studies reached it within 21 months; a quarter within 10 and three quarters within 39.

Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 5, 2026: primary completion Dec 2023 → May 2024 and completion Mar 2024 → May 2024.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Dec 10, 2019
First posted
Jan 9, 2020
StartActual
Oct 28, 2019
Primary completionActual
May 1, 2024was Dec 2023
CompletionActual
May 17, 2024was Mar 2024
Last update
Nov 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Completed
changed Nov 5, 2026
Sites
1 site added, 1 site removed
Show site
  • German Diabetes Center · Düsseldorf, Germany
Show 1 removed
  • German Diabetes Center · Düsseldorf, Germany
Nov 5, 2026
Primary completion
Dec 31, 2023→May 1, 2024 (actual)
Nov 5, 2026
Study completion
Mar 1, 2024→May 17, 2024 (actual)
Nov 5, 2026
Enrollment
24 (estimated)→20 (actual)
Nov 5, 2026
Show all 1 update
  1. Nov 5, 2026
    Recruiting→Completed
    1 site added, 1 site removed
    Show site
    • German Diabetes Center · Düsseldorf, Germany
    Show 1 removed
    • German Diabetes Center · Düsseldorf, Germany
    Primary completion Dec 31, 2023→May 1, 2024 (now actual)
    Study completion Mar 1, 2024→May 17, 2024 (now actual)
    Enrollment 24 (estimated)→20 (actual)
    + 4 other changes: verification date, contact details, references and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT04222231
Lead sponsor
German Diabetes Center
Responsible party
Sponsor
First posted
Jan 9, 2020
Start date
Oct 28, 2019
Primary completion
May 1, 2024
Completion
May 17, 2024
Last update
Nov 5, 2026

Study contacts

Michael Roden, Prof., MD
study director · German Diabetes Center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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