Trial results for the Intensive Aerobic and Resistance Exercise Program (IAREP) intervention in patients with Type 2 Diabetes Mellitus and cognitive impairment were posted on ClinicalTrials.gov on 2026-02-19. The study found that high-risk participants receiving the IAREP intervention showed a median change of -0.8 on a cognitive function scale, compared to 0.0 in the control group.
Background
Type 2 Diabetes Mellitus (T2DM) is a chronic metabolic condition characterized by high blood sugar. Beyond its well-known effects on cardiovascular and renal health, T2DM is increasingly recognized for its association with cognitive impairment and an increased risk of cognitive decline. This cognitive dysfunction can range from subtle memory issues to more severe forms, significantly impacting patients' quality of life and ability to manage their disease. Current management strategies for T2DM primarily focus on glycemic control and cardiovascular risk reduction, but interventions specifically targeting cognitive health in this population are an area of ongoing research. Exercise, known for its broad health benefits, is being explored as a potential non-pharmacological approach to mitigate cognitive decline in individuals with T2DM.
Trial design
This completed study, identified as Phase NA, enrolled 58 participants with Type 2 Diabetes Mellitus, Cognitive Impairment, Non-insulin-dependent Diabetes Mellitus, and Cognitive Dysfunction. The trial investigated a 12-week Intensive Aerobic and Resistance Exercise Program (IAREP) intervention. The study aimed to evaluate the effectiveness of IAREP on cognition, metabolic and inflammatory health, physical function, vascular health, and health practice behavior in the T2DM population, specifically stratifying subjects into high-risk and low-risk groups for cognitive impairment. Participants were assigned to either the IAREP intervention group or a control group.
Key results
The trial results included measurements of cognitive function using several scales, with findings stratified by risk:
- Change in Cognitive Function Based on Risk Stratification Score (RSS):
- For high-risk participants, the intervention group showed a median change of -0.8 score on a scale, while the control group showed a median change of 0.0 score on a scale.
- For low-risk participants, the intervention group showed a median change of -0.2 score on a scale, while the control group showed a median change of -0.1 score on a scale.
- Number of Participants With Change in Cognitive Function (Cognitive Impairment) Based on Vascular Dementia Battery (VDB):
- Among high-risk participants, 8 participants in the intervention group showed a change in cognitive impairment, compared to 14 participants in the control group.
- Among low-risk participants, 10 participants in the intervention group showed a change in cognitive impairment, compared to 16 participants in the control group.
- Change in Cognitive Function Based on the Montreal Cognitive Assessment (MoCA):
- For high-risk participants, the intervention group had a median score of 25.0 score on a scale, and the control group had a median score of 24.0 score on a scale.
- For low-risk participants, the intervention group had a median score of 25.0 score on a scale, and the control group had a median score of 24.5 score on a scale.
What this means
The results suggest that a 12-week Intensive Aerobic and Resistance Exercise Program (IAREP) may offer benefits for cognitive function in individuals with Type 2 Diabetes Mellitus and cognitive impairment, particularly for those identified as high-risk. The more pronounced negative change (indicating improvement) in the Risk Stratification Score (RSS) for high-risk intervention participants, alongside fewer participants showing a change in cognitive impairment based on the Vascular Dementia Battery (VDB) in the intervention groups, points towards a potential positive impact of exercise. These findings underscore the importance of physical activity as a non-pharmacological strategy that could be integrated into the comprehensive care plan for T2DM patients to support cognitive health, especially for those at higher risk of cognitive decline.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT06401733, titled "Intensive Aerobic and Resistance Exercise Program (IAREP)", were posted on 2026-02-19 on clinicaltrials.gov.
