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NCT Number: NCT06825182

Current Status of Islet Alpha Cell Function in Patients with Type 2 Diabetes

By detecting the fasting and postprandial 120-minute glucose, insulin (Insulin, INS), C-peptide (C-peptide, Cp), glucagon (GCG) levels in newly diagnosed type 2 diabetes patients, or the 0-minute, 30-minute, 120-minute glucose, INS, Cp, GCG levels during the Oral Glucose Tolerance Test (OGTT), and examining the glucose, INS, Cp, GCG levels during hypoglycemia, the current status of islet alpha cell function in diabetic patients is observed. Type 2 diabetes patients willing to participate are treated with GLP-1RA for 3 months, and then retested for fasting and postprandial 120-minute glucose, INS, Cp, GCG, or the 0-minute, 30-minute, 120-minute glucose, INS, Cp, GCG during OGTT, as well as the counter-regulatory hormone levels during hypoglycemia, to assess the improvement of islet alpha cell function by GLP-1RA.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nanjing First Hostital

Nanjing, Jiangsu, 210000, China

Location status: Recruiting

Location contact

Ma Jian Hua, Doctor

CONTACT

[email protected]

+8618951670116

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Willing to participate voluntarily and able to sign the Informed Consent Form before the trial;
  • Newly diagnosed patients with type 2 diabetes, aged 18 years or older, meeting the WHO 1999 diagnostic criteria;
  • Subjects who are capable and willing to maintain a regular diet and exercise regimen.

Exclusion criteria

  • Patients who are allergic to GLP-1RA or have a BMI less than 24 kg/m^2;
  • History of using blood sugar-lowering medications;
  • Estimated glomerular filtration rate (eGFR) less than 30 ml/(min*1.73 m^2);
  • History of drug abuse or alcohol dependence within the past 5 years;
  • Patients with poor compliance and irregular diet and exercise;
  • History of diagnosed pancreatitis, pancreatic tumor, medullary thyroid carcinoma, or diabetic retinopathy stage IV or higher;
  • Patients who have used systemic glucocorticoid therapy within the past 3 months;
  • Presence of infection or stress within the past four weeks;
  • Any other significant condition or comorbidity judged by the researcher, such as severe cardiopulmonary disease, endocrine disorders, neurological disorders, tumors, other pancreatic diseases, mental illness, history of alcohol or drug abuse.

Treatment and study plan

Outpatient newly diagnosed type 2 diabetes subjects

Drug

Outpatient newly diagnosed type 2 diabetes subjects, who have signed the informed consent form, meet the inclusion and exclusion criteria, and have their demographic data collected, including height, weight, systolic and diastolic blood pressure, and calculation of the body mass index (BMI) = weight/height^2 (kg/m^2). Fasting and postprandial 120-minute glucose, insulin (INS), C-peptide (Cp), and glucagon (GCG) levels are measured, or an Oral Glucose Tolerance Test (OGTT) is performed, measuring glucose, INS, Cp, GCG at 0, 30, and 120 minutes, and renal function and HbA1c are tested, with eGFR calculated. Type 2 diabetes patients are treated with GLP-1RA for three months, and then the aforementioned indicators are retested to complete the study.

Inpatient newly diagnosed type 2 diabetes subjects

Drug

Demographic data are collected. Fasting and postprandial 120-minute glucose, insulin (INS), C-peptide (Cp), and glucagon (GCG) levels are measured, or an Oral Glucose Tolerance Test (OGTT) is conducted, measuring glucose, INS, Cp, GCG at 0, 30, and 120 minutes, and renal function and HbA1c are tested. During hospitalization, if hypoglycemic symptoms occur or peripheral blood glucose or continuous glucose monitoring is ≤3.9 mmol/L, immediate venous blood is drawn for glucose, GCG, adrenocorticotropic hormone (ACTH), cortisol (Cor), growth hormone (GH), and Cp testing. Patients are treated with GLP-1RA for three months, then the aforementioned indicators are retested to complete the study and hypoglycemia (including hypoglycemic clamp and hypoglycemia tests) is assessed for glucose and GCG, with additional tests for ACTH, Cor, GH, and Cp if conditions permit, to complete the study.

Primary outcomes

  1. Glucagon levels

    Time frame: 19 months

    Compare the glucagon levels in diabetic subjects during hyperglycemia and hypoglycemia, and the changes in GCG after 3 months of GLP-1RA treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Jianhua Ma, professor

CONTACT

[email protected]

18951670116

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Registry information

Official study title

Survey on the Current Status of Islet Alpha Cell Function in Patients with Type 2 Diabetes and Interventional Study of GLP-1RA: a Multicenter, Prospective Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 13, 2025
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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