NCT03919656

SGLT-2 Inhibition, Metabolomics and Cardiovascular/Kidney Disease

SGLT-2 Inhibition and Cardiovascular Disease. Metabolomics Study of Potential Factors Involved in Cardio- and Nephroprotection

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the metabolomics changes associated with dapagliflozin treatment in patients with type 2 diabetes mellitus (T2DM). The participants in the study will be randomized to receive 10 mg dapagliflozin or placebo once daily for 12 weeks.

Detailed description

In this study, we hypothesize that metabolomics changes that occur in patients with T2DM after initiating SGLT2i (sodium-glucose cotransporter 2 inhibitors) treatment may be responsible for the beneficial cardiovascular and kidney effects observed in clinical trials with SGLT2i. Also, we propose that the study of the specific metabolome associated with the treatment with SGLT2i could help identify the possible metabolites and molecules that reduce CVD (cardiovascular disease) and renal disease in patients with T2DM. The participants in the study will be randomized to receive 10 mg dapagliflozin or placebo once daily of for 12 weeks. Besides, all participants will be advised to engage in 150 min or more of moderate-to vigorous intensity physical activity per week, spread over at least 3 days/week, with no more than 2 consecutive days without activity and to engage in 2-3 sessions/week of resistance exercise on nonconsecutive days. Moreover, these patients will be advised to follow a lifestyle program that achieve a 500-750 kcal/day energy deficit or provide≈1,200-1,500 kcal/day for women and 1,500-1,800 kcal/day for men, adjusted for the individual's baseline body weight.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Dapagliflozin 10 mg	Dapagliflozin 10 mg daily in a green, plain, diamond shaped, film coated tablet (orally)
DRUG	Placebo Oral Tablet	Green, plain, diamond shaped, film coated tablet (orally). Does not contain active ingredient

Timeline

• Start date: 2019-05-12
• Primary completion: 2024-01-12
• Completion: 2024-05-23
• First posted: 2019-04-18
• Last updated: 2025-06-15

Locations

1 site across 1 country: Spain