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Study for the related factors affecting the changes of islet function in ketosis-prone Obese diabetic patients

Study for the related factors affecting the changes of islet function in ketosis-prone Obese diabetic patients

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900025909
Enrollment
Unknown
Registered
2019-09-14
Start date
2016-07-01
Completion date
Unknown
Last updated
2019-09-16

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

Conditions

ketosis-prone Obese diabetic

Interventions

ketosis-prone Obese diabetic group:conventional therapy
Obese type 2 diabetes mellitus group:conventional therapy
Type 1 diabetic ketosis group:conventional therapy

Sponsors

Department of Endocrinology, Changzhou No. 2 Peoples’ Hospital Affiliated to Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Aged 18 - 70 years. Diagnostic criteria for diabetes mellitus were specified in accordance with the American Diabetes Association (ADA, 1997). Ketosis-prone Obese diabetic group: 1. diabetic ketosis, Blood glucose level > 13.9mmol/L; 2. Urine ketones > 2+ (80mg/dl) or / and pH level =28kg/m2; 4. The absence of IAAICAs and GAD 65 autoantibodies. Obese type 2 diabetes mellitus group: 1. The absence of IAAICAs and GAD 65 autoantibodies; 2. Fasting serum C-peptide level > 1.1ng/ml; 3. BMI>=28kg/m2; 4. Urine ketones negative. Type 1 diabetic ketosis group: 1. The course of diabetes mellitus = 12 months, continuous insulin treatment; 2. Urine ketones > 2+ (80mg/dl) or / and pH level < 7.30. 3. In C-peptide release test, Fasting C-peptide values <=1.0 ng / ml, peak C-peptide values <=1.5ng/ml; 4. At least one positive of the autoantibodies to IAAICAs and GAD 65; 5. BMI < 24kg/m2.

Exclusion criteria

Exclusion criteria: 1. There are or pregnancy or stress conditions (such as infection, surgery, trauma and so on); 2. Drugs (such as glucocorticoids) that affect glucose and lipid metabolism were taken within 1 month; 3. Ischemic heart, cerebrovascular disease or acute and chronic cardiac insufficiency; 4. Hyperglycemia caused by special types of diabetes, such as pancreatic exocrine diseases or other endocrine diseases; 5. Severe liver and kidney diseases (glutamic-pyruvic transaminase 2.5 times higher than the basic value, serum creatinine >=124umol/l).

Design outcomes

Primary

MeasureTime frame
HbA1c;blood-glucose;Serum C peptide;free fatty acids;beta-hydroxybutyric acid;insulin sensitivity index;

Secondary

MeasureTime frame
blood pressure;Height;weight;total cholesterol;triglyceride;high density lipoprotein;low density lipoprotein;

Countries

China

Contacts

Public ContactShi Li

Changzhou 2nd People's Hospital Affiliated to Nanjing Medical University

shili1204@sina.com+86 13861193196

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 28, 2026