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GLP-1 receptor agonists as preventive treatment of diabetes after renal transplantation: a single-arm interventional clinical trial. Study 2: Patients on the waiting list for kidney transplantation.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506436-33-00
Enrollment
20
Registered
2023-12-01
Start date
2024-03-22
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic syndrome in patients on the waiting list for kidney transplantation

Brief summary

Proportion of patients with reversal of metabolic syndrome after 3 and 6 months of GLP1RA initiation defined by correction of metabolic syndrome (must be reduced to 1 or less defining criteria) by: (a) correction of pre-diabetes as determined by:  fasting plasma glucose of 100-126 mg/dL (5.6-6.9 mmol/L),  and/or impaired fasting glucose of <126 mg/dL (7 mmol/L) with 2 h plasma glucose after an oral glucose of 140-200 mg/dL (7.8-11 mmol/L)

Detailed description

Insulin sensitivity as measured by assessment of the homeostatic model calculated for insulin resistance score (HOMA-IR) and β-cell function as measured by the HOMA index of β-cell function (HOMA-B) at study inclusion, 3 and 6 months after initiation of therapy., Adverse Reactions: Gastrointestinal (nausea or diarrhea), pancreatitis, headaches, injection site pain, weakness, and severe hypoglycemic episodes defined as an episode requiring the assistance of another person to actively administer carbohydrate, glucagon, or take other corrective measures), rate of treatment discontinuation at 3 and 6 months after initiation of therapy., Changes in abdominal obesity (waist circumference and change in waist-hip ratio since enrollment in the study, at 3 and 6 months after the start of therapy)., Rate of treatment interruptions

Interventions

Sponsors

Bellvitge University Hospital, Fundacio Institut D'Investigacio Biomedica De Bellvitge IDIBELL
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Proportion of patients with reversal of metabolic syndrome after 3 and 6 months of GLP1RA initiation defined by correction of metabolic syndrome (must be reduced to 1 or less defining criteria) by: (a) correction of pre-diabetes as determined by:  fasting plasma glucose of 100-126 mg/dL (5.6-6.9 mmol/L),  and/or impaired fasting glucose of <126 mg/dL (7 mmol/L) with 2 h plasma glucose after an oral glucose of 140-200 mg/dL (7.8-11 mmol/L)

Secondary

MeasureTime frame
Insulin sensitivity as measured by assessment of the homeostatic model calculated for insulin resistance score (HOMA-IR) and β-cell function as measured by the HOMA index of β-cell function (HOMA-B) at study inclusion, 3 and 6 months after initiation of therapy., Adverse Reactions: Gastrointestinal (nausea or diarrhea), pancreatitis, headaches, injection site pain, weakness, and severe hypoglycemic episodes defined as an episode requiring the assistance of another person to actively administer carbohydrate, glucagon, or take other corrective measures), rate of treatment discontinuation at 3 and 6 months after initiation of therapy., Changes in abdominal obesity (waist circumference and change in waist-hip ratio since enrollment in the study, at 3 and 6 months after the start of therapy)., Rate of treatment interruptions

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026