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Obesity Treatment to Improve Diabetes

NCT05390307 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-02-28

No results posted yet for this study

Summary

As the obesity pandemic continues unabated, one can expect to see an increase in the prevalence of TID/T2D and associated CKD. As a result, death will rise, preceded by an increase in kidney failure, requiring dialysis and renal transplantation. Innovative medical treatment may help prevent chronic kidney disease (CKD) across our healthcare system. The guideline of the American Diabetes Association (ADA) and European Association for the Study of Diabetes (EASD) suggest that patients with obesity, TID/ T2D, and CKD needed either glucagon-like peptide 1 receptor analogs (GLP1-RA) or sodium-glucose cotransport-2 inhibitors (SGLT2i). If neither achieve metabolic control, then the recommendation is to combine both drugs. The evidence base for combining GLP1RA and SGLT2i are not well developed, and hence the impact of the guidelines are limited. This study will provide evidence of discrete metabolic pathways by the GLP1RA/or SGLT2i alone or in combination contributed to metabolic control. The aim of this randomised control trial (RCT) is to test the impact of the combination of GLP1RA/SGLT2i on body weight and kidney damage, in patients with T1DM and CKD. In addition, we will explore associated changes in metabolic pathways with each of the treatments used in the RCT.

Conditions

Interventions

DRUG

Liraglutide / Semaglutide

Liraglutide 3mg once daily or semaglutide 1mg once weekly subcutaneous injection for 6 months.

DRUG

Dapagliflozin

Dapagliflozin 5-10 mg once daily for 6 months.

DRUG

Liraglutide or Semaglutide / Dapagliflozin

Combined treatment with Liraglutide 3mg once daily or semaglutide 1mg once weekly subcutaneous injection plus Dapagliflozin 5-10 mg once daily for 6 months.

DRUG

Liraglutide or Semaglutide / Dapagliflozin plus intensive weight loss nutrition

Liraglutide 3mg once daily or semaglutide 1mg once weekly subcutaneous injection plus Dapagliflozin 5-10 mg once daily for 6 months combined with intensive lifestyle changes.

OTHER

Usual care

Usual standard care

Sponsors & Collaborators

  • Dasman Diabetes Institute

    lead OTHER

Principal Investigators

  • Ebaa Al Ozairi · Dasman Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2024-01-01
Completion
2024-01-01

Countries

  • Kuwait

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05390307 on ClinicalTrials.gov