Status:
COMPLETED
Obesity Treatment to Improve Diabetes
Lead Sponsor:
Dasman Diabetes Institute
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
21-65 years
Phase:
NA
Brief 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, ...
Detailed Description
Obesity and CKD are linked by obesity-related insulin resistance, a prodromal state associated with impaired glucose tolerance, dyslipidemia, and hypertension, which frequently progresses to overt T1D...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- To be considered eligible to participate in this study, a patient must:
- Be aged between 21-65 years,
- Have a BMI ≥ 25 kg/m2,
- Have established diagnosis of Type 1 Diabetes for at least 1 year before screening visit
- Insulin treatment for T1D - may be either via any FDA approved insulin pump (CSII) for at least 6 months prior to screening visit or via multiple daily insulin injections. All participants must be stable on insulin doses/ regimen for at least 3 months
- Have established diagnosis of Chronic Kidney Disease stage 1-4
- Able to give informed consent
- Exclusion criteria:
- Participants will be excluded if:
- Have been treated with GLP-1 or SGLT2i within the last 3 months and/or have a history of GLP1RA or SGLT2i intolerance
- Diagnosis of T2D or any other type of diabetes (other than type 1)
- Treatment with anti-obesity drugs within 12 weeks prior to randomisation
- Significant changes in the lifestyle (Diet or exercise pattern in within 3 months of the screening visit)
- Any self reported changes (gain or loss) in body weight \>5% within 3 months of screening visit
- eGFR ≤15 mL/min/1.73m2
- Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using or willing to use adequate contraceptive methods during the study period
- Experienced diabetic ketoacidosis within 6 months of screening visit
- Experienced sever hypoglycaemia within 6 months of screening visit
- Any of the following laboratory values at screening (liver chemistry \> 3X upper limit of normal, high Tg (. 5.7 mmol/L)
- Have terminal illness or are not primarily responsible for their own care
- Any other significant disease or disorder which in the opinion of the investigator, may either put the participants at risk or may influence the result of the study or the participant's ability to participate
- Untreated or uncontrolled hypothyroidism/hyperthyroidism defined as thyroid-stimulating hormone \>6 mIU/litre or \<0.4 mIU/litre
- Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC)
- Personal history of non-familial medullary thyroid carcinoma
- History of chronic pancreatitis or idiopathic acute pancreatitis
- Amylase levels three times higher than the upper normal range
- Obesity induced by other endocrinologic disorders (e.g. Cushing's Syndrome)
- Current or history of treatment with medications that may cause significant weight gain, within 12 weeks prior to randomisation, including systemic corticosteroids (except for a short course of treatment, i.e. 7-10 days), atypical antipsychotic and mood stabilizers (e.g. clozapine, olanzapine, valproic acid and its derivatives, and lithium)
- Initiation of antidepressants during the last 12 weeks
- Previous surgical treatment for obesity (excluding liposuction if performed \>1 year before trial entry)
- History of other severe psychiatric disorders
- History of known or suspected abuse of alcohol and/or narcotics
- History of major depressive episode during the last 2 years
- Simultaneous participation in other clinical trials of investigational drugs, lifestyle or physical activity interventions. Patients will only be able to take part following participation in a previous clinical trial after a wash-out period of 16 weeks.
- History of dementia or cognitive impairment
Exclusion
Key Trial Info
Start Date :
April 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05390307
Start Date
April 1 2023
End Date
January 1 2024
Last Update
February 28 2024
Active Locations (1)
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1
Dasman Diabetes Institute
Kuwait City, Al Asimah, Kuwait, 15462