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AI-assisted Multi-domain Lifestyle Versus Tirzepatide for Weight Loss Maintenance in Adults With Type 2 Diabetes (AIM-MAINTAIN)

ConditionsOverweight or Obesity; Type 2 DiabetesWeight Loss Maintenance
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHuazhong University of Science and Technology

About this trial

This is a randomized controlled trial to compare the effect of AI-assisted multi-domain lifestyle and continued tirzepatide on body weight loss maintenance. The study consists of two phases: a 20-week lead-in phase, during which all participants will receive weekly subcutaneous tirzepatide at the maximum tolerated dose (MTD), followed by a 52-week intervention phase.

Participants who meet the randomization criteria after the lead-in phase will be randomly assigned to either AI-assisted multi-domain lifestyle intervention or tirzepatide 5 mg

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female participants aged 18 to 65 years at the time of signing informed consent;

Body Mass Index (BMI) ≥27.0 kg/m²;

Type 2 diabetes mellitus diagnosed by physicians within the past 5 years prior to screening.

Voluntary participation and provide written informed consent.

Disqualifiers

History of type 1 diabetes mellitus or other types of diabetes, or treatment with insulin.

History of obesity attributable to endocrine disorders or monogenic mutations.

A self-reported change in body weight ≥5.0% within 3 months prior to the day of screening.

Use of medications or products causing weight changes or affecting weight assessment within 3 months prior to the day of screening;

Trial design

Design model

Parallel

Treatments tested in this trial

  • AI assisted multi-domain lifestyle intervention

    Behavioral

    AI-assisted multi-domain lifestyle interventions that integrate dietary, physical activity, and psychological components.

  • Tirzepatide

    Drug

    Administered subcutaneously.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: AI assisted multi-domain lifestyle interventionExperimental treatment 1 intervention
Group B: TirzepatideActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Body weight change (kg)

Weight will be measured to the nearest 0.1 kg

Time frame
Change from randomization (week 20) to week 72

Secondary outcomes

1

Percent change in body weight

Percent change from week 20 to week 72

Time frame
Change from randomization (week 20) to week 72
2

Body mass index

Weight / Height\^2 (kg/m²)

Time frame
Change from randomization (week 20) to week 72
3

Waist and hip circumference

Waist and hip circumference will be measured to the nearest 0.1cm

Time frame
Change from randomization (week 20) to week 72
4

Body fat percentage

Change in body fat percentage (BF%) from randomization to the week 72

Time frame
Change from randomization (week 20) to week 72

Other outcomes

1

Concentration of high-sensitivity C-reactive protein (hs-CRP)

Concentration of hs-CRP, measured in mU/L

Time frame
Change from baseline (week 0) to week 72
2

HOMA-IR

Fasting insulin (μU/mL) \* fasting glucose (mmol/L) / 22.5

Time frame
Change from baseline (week 0) to week 72
3

HOMA-β

20\*Fasting insulin(μU/mL)／\[fasting glucose (mmol／L)-3.5\]

Time frame
Change from baseline (week 0) to week 72
4

Visceral fat

MRI will be performed to measure liver and pancreatic fat

Time frame
Change from baseline (week 0) to week 72

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Huazhong University of Science and Technology

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: