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Exploration of treatment of newly diagnosed overweight / obese type 2 diabetes mellitus

Exploration of treatment of newly diagnosed overweight / obese type 2 diabetes mellitus

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000040656
Enrollment
Unknown
Registered
2020-12-06
Start date
2020-12-01
Completion date
Unknown
Last updated
2021-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diatetes

Interventions

Sponsors

Beijing Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Subjects must meet all of the following criteria to be enrolled: patients aged 18 years or older and less than 65 years old, who (1999) diagnostic criteria for type 2 diabetes mellitus, patients with diabetes duration =25kg / m2, HbA1c 7.0% to 9.0%, stable weight (weight fluctuation < 5% in the first three months), signing informed consent and complying with the study protocol.

Exclusion criteria

Exclusion criteria: Subjects were excluded from the study if any of the following exclusion criteria were met. Diabetes mellitus other than type 2 diabetes mellitus clinically diagnosed; there were acute metabolic complications within 6 months before screening, including lactate acidosis, nonketotic hyperosmolar coma and diabetic ketoacidosis; those with severe acute and chronic complications of diabetes mellitus (such as myocardial infarction, cerebrovascular accident, congestive heart failure, blindness caused by diabetic retinopathy, renal failure and Severe foot ulcer, etc. Patients with endocrine diseases other than type 2 diabetes mellitus who are under treatment and not under control; hypoglycemia patients who are easy to relapse according to researchers' judgment; drugs affecting body weight (such as orlistat, glucocorticoid, etc.) or drugs affecting appetite and gastrointestinal motility in recent 3 months; severe liver function injury (ALT >=3 ULN); severe renal insufficiency (EGFR 70 g/week); Patients with mental disorders, unable to cooperate with the test, unable to eat by mouth, patients with gastrointestinal surgery history, patients with intolerance or allergy to the ingredients of meal replacers, allergic to metformin and engelgelin, pregnant and lactating women, tumor history within 5 years.

Design outcomes

Primary

MeasureTime frame
glycosylated hemoglobin;

Countries

China

Contacts

Public ContactLixin Guo

Department of Endocrinology, Beijing Hospital

glx1218@163.com+86 13901317569

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026