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OpenTrials
Active, not recruiting

NCT Number: NCT07763795

Effects of BFRT on Glycemic Control, Nerve Conduction, Functional Outcomes and QOL in Individuals With Type 2 Diabetes

Diabetic peripheral neuropathy is one of the most prevalent complications of Type 2 Diabetes Mellitus. Peripheral neuropathy is caused by unavailability of glucose in cells and low metabolism. The Blood flow restriction training cause glucose diffusion into cell and Angiogenesis.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Diabetic Neuropathy Peripheral

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sahiwal Diabetes and Foor care Clinic

Sahiwal, Punjab Province, Pakistan

About this study

The objective of this study will be to determine the effect of Blood flow restriction training on peripheral neuropathy in diabetes II patients. The study will be randomized controlled trial. Sample size will be determined by pilot study.

The single blinding will be applied. Randomization will be done by lottery method.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • type 2 diabetes (≥5 years) patients diagnosed
  • random blood glucose ≥ 11.1mmol/L;
  • fasting blood glucose ≥ 7.0 mmol/L
  • Haemoglobin A1c 6.5%-9.5%. 2) Can walk independently, no severe joint limitations
  • Can safely perform resistance training
  • Stable diabetic & neuropathy meds for 3+ months

Exclusion criteria

  • suffers frequent hypoglycaemia,
  • severe diabetes complications
  • Diagnosed cases of neuromuscular disorders
  • history of stroke/DVT

Treatment and study plan

BFR with low resistance high repetition exercises

Combination Product

Three set(30,15,15) with 20% of 1RM(repetition maximum) along with BFR (40% LOP). Rest between sets 60s

low resistance high repetition exercises

Combination Product

Three set(30,15,15) with 20% of 1RM(repetition maximum)

Primary outcomes

  1. Glycated Hemoglobin

    Time frame: 12 Months

    HbA1c reflects the average blood glucose concentration over the 3 months by measuring the percentage of hemoglobin that is glycated.

    Scoring is as following: below 5.7% being normal, 5.7%-6.4% prediabetes, and 6.5% higher diabetes

  2. Nerve Conduction Velocity

    Time frame: 12 Months

    Nerve conduction velocity measures the speed at which an electrical impulse travels along a peripheral nerve and is used to assess the functional integrity of peripheral nerves. It is particularly useful for detecting and quantifying peripheral nerve dysfunction in diabetic neuropathy.

    Scoring:

    NCV is recorded in m/s; typical adult lower reference limits are approximately ≥40-45 m/s for lower-limb motor nerves and ≥40-50 m/s for sensory nerves, with values below the laboratory-specific reference range considered abnormal.

  3. Numeric pain rating scale (NPRS)

    Time frame: 12 Months

    It is used to assess pain intensity

    Scoring is as following :

    its 11-point scale (0-10) 0 means "no pain" and 10 represents "worst possible pain."

  4. The Norfolk Quality of Life-Diabetic Neuropathy (QOL-DN) instrument

    Time frame: 12 Months

    The Norfolk QOL-DN measures the impact of diabetic neuropathy on overall health-related quality of life Scoring is as following :Total score of tool is 160. 0-40 score mean Mild or no impairment,41-80 score mean Moderate impairment and 81-160 mean Severe impact on quality of life.

Sponsors and collaborators

Lead sponsor

Superior University

Other

Registry information

Official study title

Effects of Blood Flow Restriction Training on Glycemic Control, Nerve Conduction, Functional Outcomes and Quality of Life in Individuals With Type 2 Diabetes Peripheral Neuropathy

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Aug 13, 2026
Registry last updated
Aug 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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