Tirzepatide, a gut hormone-based medication, has shown promising results in treating obesity, with \~22% weight loss and mild side effects. However, patients with type 2 diabetes typically experience only about 15% weight loss with tirzepatide, despite tolerating the medication well. Its effects in people with both obesity and type 1 diabetes remain largely unknown. Although tirzepatide is not approved for glycemic control in type 1 diabetes, it is licensed for obesity treatment in Gulf and Europe. In Kuwait, more than a quarter of people with type 1 diabetes also have obesity, presenting a unique opportunity to study tirzepatide's impact. This randomized, double-blind controlled trial will evaluate the safety and efficacy of tirzepatide in patients with type 1 diabetes and obesity, comparing usual care with the maximum tolerable dose of tirzepatide to assess its impact on weight loss. The findings may help address important safety concerns and have the potential to inform and influence future clinical practice.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
weekly injections
weekly injections
Dasman Diabetes Institute
Kuwait City, Sharq, Kuwait
RECRUITINGBodyweight
Percent body weight change (%)
Time frame: 76 weeks
HbA1c
Change in HbA1c levels (%)
Time frame: 76 weeks
Time in range
Change in continuous glucose monitoring (CGM) metrics (time in range (3.9-10mmol/L))
Time frame: 76 weeks
Systolic Blood pressure
Change in blood pressure
Time frame: 76 weeks
Diastolic Blood pressure
Change in blood pressure
Time frame: 76 weeks
Time in hypoglycaemia
Change in continuous glucose monitoring (CGM) metrics (time in hypoglycaemia (mild \< 3.9, severe \< 2.5mmol/L))
Time frame: 76 weeks
Total cholesterol
Change in lipid parameters (total cholesterol)
Time frame: 76 weeks
HDL
Change in lipid parameters (HDL)
Time frame: 76 weeks
Triglycerides
Change in lipid parameters (Triglycerides)
Time frame: 76 weeks
LDL
Change in lipid parameters (LDL)
Time frame: 76 weeks
SF-36 (36-Item Short Form Survey) for Quality of life
Quality of life will be assessed using SF-36 questionnaires. Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state.
Time frame: 76 weeks
CRP
Inflammatory markers will be assessed through blood tests.
Time frame: 76 week
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