Impaired Glucose Tolerance Clinical Trial
Official title:
Evaluation of the Safety and Efficacy of SGLT2 Inhibitors in Pre-diabetic Patients: A Randomized Trial
Pre-diabetes is a state characterized by subclinical impairment in glycemic variables that is intermediate between normal glucose tolerance (NGT) and diabetes. There are two frequently used definitions for pre-diabetes, one from the American Diabetes Association (ADA) and another from the World Health Organization (WHO), and both include impaired glucose tolerance (IGT), impaired fasting glucose (IFG), and a calibrated hemoglobin A1c (HbA1c) of between 5.7 and 6.4%. More than 30 % of the global population demonstrated one or more forms of prediabetic dysglycaemia. In general, approximately 70 % of individuals with IFG and/or IGT can expect to go on to develop clinical type 2 diabetes at some time in the future, and the risk increases with higher HbA1c levels and with higher BMI. Worse still, the prevalence of pre-diabetes is increasing worldwide, with a growing number of patients progressing to diabetes. Identification and treatment of pre-diabetic individuals is therefore crucial. Recent evidence suggested that preventing progression of pre-diabetes to diabetes is possible, and thus efficacious interventions for pre-diabetic individuals are the cornerstone of diabetes prevention. The current paradigm for diabetes prevention in high-risk individuals focuses on achieving moderate weight loss via dietary change and increasing physical activity. However, lifestyle-based weight-loss strategies may initially be successful, but difficult to achieve or maintain. In many cases, pharmacologic treatments may be needed to regulate blood glucose. Randomized clinical trials (RCTs) have verified the efficacy of metformin in preventing insulin resistance syndrome, along with the progression of microvascular diseases and heart attacks. Meanwhile, clinical experience and trial data have yielded almost no significant safety concerns for metformin. Nonetheless, it may cause discomfort for up to 25% of patients who experience diarrhea and nausea subsequent to its administration. For patients with a contraindication or intolerable adverse effects to metformin, Sodium Glucose Cotransporter 2 (SGLT-2) inhibitors with novel mode of action may be another alternative. Large clinical trials have not yet identified a substantial elevation in the frequency of adverse reactions related to SGLT-2 inhibitors when compared to the placebo group. Inhibition of SGLT-2 has some extra advantages for diabetes management over other therapeutic approaches. Firstly, the SGLT-2 is exclusively expressed in renal proximal tubules, and thus selective inhibitors will exert a glucose-lowering effect, independently of insulin secretion. Therefore, SGLT-2 inhibitors can cause weight loss without inducing major hypoglycemic events. Secondly, the cardiovascular benefits of SGLT-2 inhibitors was supported by large clinical trials in the modern context of antiplatelet, statin, and blood pressure management, which may match many of the advantages of metformin. Thirdly, SGLT-2 inhibitors have also been proven to prevent nephropathy for its restriction on albuminuria and inflammatory processes, and to subsequently dampen the deterioration in renal function. Overall, SGLT-2 inhibitors have demonstrated safety in non-diabetic patients, particularly in those afflicted with heart or kidney failure, and have shown to provide additional benefits. At present, the overall effectiveness and safety of SGLT-2 inhibitors in improving metabolism of pre-diabetic patients are still unclear. The purpose of this experiment is to evaluate the effect of SGLT-2 inhibitor on pre-diabetic patients.
Status | Not yet recruiting |
Enrollment | 120 |
Est. completion date | December 1, 2025 |
Est. primary completion date | June 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. Aged 18 ~65 years old; 2. OGTT received within half a year and were diagnosed with prediabetes In accordance with the gout classification criteria of the American Diabetes Association: ? Fasting blood glucose (FPG)=6.1 mmol/L and < 7.0 mmol/L; ? The blood glucose (2h-PG) concentration at OGTT 2h was =7.8 and < 11.1mmol/L; ? Glycosylated hemoglobin (HbA1c) =5.7% and < 6.4%; 3. No antidiabetic drugs (including traditional Chinese medicine) were taken within 6 months before screening; 4. Sign the informed consent form. Exclusion Criteria: 1. Diagnosed with diabetes; 2. Taking medications that affect glucose and lipid metabolism (excluding thiazide diuretics at a daily dose of = 12.5 mg); 3. Taking weight-loss drugs (including traditional Chinese medicine) within 6 months before screening; 4. Patients with acute infection, surgery, acute alcoholism, mental illness, etc; 5. Patients with liver and kidney dysfunction, severe chronic gastrointestinal disease, uncontrolled thyroid disease, cancer, and ventilator use; 6. Systolic blood pressure =180 mmHg (1 mmHg = 0.133 kPa) or diastolic blood pressure =110 mmHg at screening; 7. Electrocardiogram within 12 weeks before screening indicating arrhythmia requiring urgent diagnosis or treatment (e.g., clinically newly identified severe arrhythmia or conduction disturbance), myocardial infarction, unstable angina, or stroke requiring cardiovascular and cerebrovascular intervention; 8. A history of traumatic amputation within the past year, or active skin ulcers, osteomyelitis, gangrene, or critical lower limb ischemia within the past 6 months; 9. Enrolled in drug/device clinical studies (including vaccines) within 12 weeks before screening; 10. Pregnant, lactating women, or those planning a recent pregnancy; 11. Allergic constitution or multi-drug allergy; 12. Receiving bariatric surgery within the past 2 years. |
Country | Name | City | State |
---|---|---|---|
China | Peking University Third Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Yangjin | Peking University Third Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 2h plasma glucose on an oral glucose tolerance test (OGTT) | 2h-PG change | Change from baseline (time 0) to study end (12 weeks) | |
Secondary | Change in HbA1c | fasting serum HbA1c change | Change from baseline (time 0) to study end (12 weeks) | |
Secondary | Change in Body Weight | fasting body weight change | Change from baseline (time 0) to study end (12 weeks) | |
Secondary | Change in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | Change in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | Change from baseline (time 0) to study end (12 weeks) | |
Secondary | Change in Waist Circumference (WC) | Change in Waist Circumference (WC) | Change from baseline (time 0) to study end (12 weeks) | |
Secondary | Glycemic control including Fasting Blood Glucose (FBG) and Glycosylated Hemoglobin (HbA1C) | Glycemic control including Fasting Blood Glucose (FBG) and Glycosylated | Change from baseline (time 0) to study end (12 weeks) | |
Secondary | Plasma lipid fractions including Total Cholesterol Levels (CHOL) and Triglyceride (TRG) Levels | Plasma lipid fractions including Total Cholesterol Levels (CHOL) and Triglyceride | Change from baseline (time 0) to study end (12 weeks) | |
Secondary | Liver Enzymes including ALT and AST levels | Liver Enzymes including ALT and AST levels | Change from baseline (time 0) to study end (12 weeks) | |
Secondary | Creatinine, calculated eGFR, and Albumin/Creatinine Ratio (ACR) | Creatinine, calculated eGFR, and Albumin/Creatinine Ratio (ACR) | Change from baseline (time 0) to study end (12 weeks) |
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