ACTIVE_NOT_RECRUITING

DIALYSIS-TIR Study

Conditions

Type 2 Diabetes End Stage Renal Disease on Dialysis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study will look at control of blood sugar levels in persons with type 2 diabetes mellitus currently on chronic dialysis. Researchers will compare blood sugar levels in people taking semaglutide to people taking "dummy" medicine. The treatment participants get will be decided randomly. Participants will need to inject the study medication once a week. The study will last for 1 year and a month. Participants will be asked to wear a sensor that measures blood sugar levels for a period of 10 days at five different time points during the study.

Official Title

Semaglutide for Dialysis-Treated Patients - a Glucose Time in Range Study- DIALYSIS-TIR Study

Quick Facts

Study Start:2023-12-05

Study Completion:2028-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06042153

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Ability to provide informed consent before any trial-related activities. Trial-related activities are any procedures that are carried out as a part of trial, including activities to determine suitability for the trial. 2. Male or female Adults (age \> 18 years at the time of signing the consent) 3. Type 2 diabetes mellitus diagnosed \> 6 months prior to screening 4. On current chronic treatment with Hemodialysis or Peritoneal dialysis for \> 6 months prior to screening 5. Current treatment with any glucose lowering pharmacotherapy, at a stable dose for at least 30 days. DPP-4 Inhibitors will be allowed at study entry and will be stopped at randomization. 6. Minimum of 80% valid data on the 10-day Continuous Glucose Monitor download 7. Time in Range 15 to 60%	1. BMI \< 23 kg/m2 at screening 2. Current (within the past 90 days of screening) use of any GLP-1 RA 3. Personal or family history of medullary thyroid cancer or Multiple Endocrine Neoplasia type 2 4. Known or suspected hypersensitivity to GLP-1 RA (trial medication(s), excipients, or related products) 5. Pregnant, breast-feeding or the intention of becoming pregnant, or not using effective contraceptive measures 6. Active weight loss, defined as weight loss of \>5% of body weight in the past 3 months 7. Current participation in other interventional trials or last dose of any investigational product within 4 half- lives at the time of randomization 8. Any medical condition which in the judgement of the investigator precludes safe participation in the trial (includes, but not limited to active neoplasm, severe heart failure, recent cardiovascular event, severe frailty, planned cardiac or vascular surgeries on the day of screening etc) 9. If weight loss is not desired by the participant, or if the provider or investigator considers intentional weight loss to be detrimental to the health of the participant 10. Other or secondary forms of diabetes (like type 1 diabetes, pancreatogenic diabetes mellitus, MODY, LADA, drug induced, etc.) 11. Current diagnosis of gastroparesis or enteropathywhich in the opinion of investigator precludes safe treatment with GLP-1 RA. 12. Hypoglycaemia unawareness, or history of frequent or severe hypoglycaemia (in the opinion of the investigator) 13. Personal history of chronic pancreatitis, or acute pancreatitis within 180 days of screening 14. Known current uncontrolled or unstable retinopathy (by medical history)

Inclusion Criteria

Exclusion Criteria

1. Ability to provide informed consent before any trial-related activities. Trial-related activities are any procedures that are carried out as a part of trial, including activities to determine suitability for the trial.
2. Male or female Adults (age \> 18 years at the time of signing the consent)
3. Type 2 diabetes mellitus diagnosed \> 6 months prior to screening
4. On current chronic treatment with Hemodialysis or Peritoneal dialysis for \> 6 months prior to screening
5. Current treatment with any glucose lowering pharmacotherapy, at a stable dose for at least 30 days. DPP-4 Inhibitors will be allowed at study entry and will be stopped at randomization.
6. Minimum of 80% valid data on the 10-day Continuous Glucose Monitor download
7. Time in Range 15 to 60%

1. BMI \< 23 kg/m2 at screening
2. Current (within the past 90 days of screening) use of any GLP-1 RA
3. Personal or family history of medullary thyroid cancer or Multiple Endocrine Neoplasia type 2
4. Known or suspected hypersensitivity to GLP-1 RA (trial medication(s), excipients, or related products)
5. Pregnant, breast-feeding or the intention of becoming pregnant, or not using effective contraceptive measures
6. Active weight loss, defined as weight loss of \>5% of body weight in the past 3 months
7. Current participation in other interventional trials or last dose of any investigational product within 4 half- lives at the time of randomization
8. Any medical condition which in the judgement of the investigator precludes safe participation in the trial (includes, but not limited to active neoplasm, severe heart failure, recent cardiovascular event, severe frailty, planned cardiac or vascular surgeries on the day of screening etc)
9. If weight loss is not desired by the participant, or if the provider or investigator considers intentional weight loss to be detrimental to the health of the participant
10. Other or secondary forms of diabetes (like type 1 diabetes, pancreatogenic diabetes mellitus, MODY, LADA, drug induced, etc.)
11. Current diagnosis of gastroparesis or enteropathywhich in the opinion of investigator precludes safe treatment with GLP-1 RA.
12. Hypoglycaemia unawareness, or history of frequent or severe hypoglycaemia (in the opinion of the investigator)
13. Personal history of chronic pancreatitis, or acute pancreatitis within 180 days of screening
14. Known current uncontrolled or unstable retinopathy (by medical history)

Contacts and Locations

Principal Investigator

Ildiko Lingvay, MD, MPH, MSCS

PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Study Locations (Sites)

University of North Carolina

Chapel Hill, North Carolina, 27599

United States

Davita UT Southwestern - Oak Cliff

Dallas, Texas, 75224

United States

DaVita UT Southwestern - East Dallas

Dallas, Texas, 75228

United States

DaVita UT Southwestern - Preston

Dallas, Texas, 75240

United States

DaVita UT Southwestern - Irving

Irving, Texas, 75062

United States

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

Ildiko Lingvay, MD, MPH, MSCS, PRINCIPAL_INVESTIGATOR, University of Texas Southwestern Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-05

Study Completion Date2028-09

Study Record Updates

Study Start Date2023-12-05

Study Completion Date2028-09

Terms related to this study

Additional Relevant MeSH Terms

Type 2 Diabetes
End Stage Renal Disease on Dialysis