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NCT06820775
EFFECTIVENESS OF A TRIPLE NUTRITIONAL INTERVENTION AND PHYSICAL IN PREDIABETIC PATIENRS
NA trial testing A TRIPLE INTERVENTION NUTRITION AND PHYSICAL ACTIVITY in Diabetes in 82 participants. Not yet recruiting.
30 June 2025
Quick facts
| Lead sponsor | Bioaraba Health Research Institute |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 82 |
| Start date | 2 February 2025 |
| Primary completion | 30 June 2025 |
| Estimated completion | 30 June 2025 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- A TRIPLE INTERVENTION NUTRITION AND PHYSICAL ACTIVITY
Conditions studied
- Diabetes — all drugs for Diabetes →
Sponsor
Bioaraba Health Research Institute
Who can join
Adults 35 to 70, any sex, with Diabetes. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Diabetes represents a substantial burden on health care systems. People with prediabetes IGT (impaired glucose tolerance) or IFG (impaired fasting glucose) are at high risk of developing diabetes, and up to 50% progress to diabetes within 5 years. OBJECTIVE: To evaluate the effectiveness of a triple intervention (physical activity and ordered healthy diet) to improve glycosylated hemoglobin control in prediabetic patients. MATERIAL AND METHODOLOGY: Randomized, open, controlled clinical trial with routine clinical practice (health advice for physical activity and healthy diet). Study population: obese or overweight patients of the OSI Araba aged 35-70 years who are in the contemplation stage. Response assessment: Primary variable: glycosylated hemoglobin; Secondary variables: Body Mass Index (BMI) (kg/cm2); blood pressure (mm Hg); satisfaction questionnaire score; physical exercise index (IPAQ) (METs). Statistical analysis: The analysis of the main variable (change in HbA1c at 6 months between both groups) will be assessed by analysis of covariance, ANCOVA, adjusting for baseline HbA1c. Sample size: 41 patients per arm (+30% to cover losses to follow-up).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06820775
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Other Bioaraba Health Research Institute trials
Trials by the same sponsor.
- NCT04856943 — Effectiveness of Smartconsent in Improving Understanding of Informed Consent · NA · completed
- NCT04851795 — Effectiveness of a Supervised Hospital-based Physical Exercise · NA · unknown
- NCT06547671 — Efficacy of a Sensory Comfort Room in Agitation Control · NA · completed
- NCT04621058 — Efficacy of Vitamin D Treatment in Mortality Reduction Due to COVID-19. · Phase 3 · completed
- NCT04400630 — Functionality and Neurocognition in Patients With Bipolar Disorder After a Physical-exercise Program (FINEXT-BD Study) · NA · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06820775 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bioaraba Health Research Institute
- Last refreshed: 11 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06820775.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing