A Clinical Trial Analyzing Effects of Prokinetic Drug on the Blood Glucose in Patients With Type 2 Diabetes
Study Details
Study Description
Brief Summary
With the improvement of living level, the incidence rates of diabetes, obesity, and hypertension in China increased quickly, which are 11.6%, 7.1% and 18.8% respectively, according to the newly investigated data. The clustering of diabetes, obesity, hypertension and dyslipidemia increases the risk of cardiovascular events for patients. GLP-1 (glucagon like peptide-1) is a kind of incretin discovered in recent years. It was reported that beside its hypoglycemic and losing weight effects, activator of GLP-1 receptor could decrease blood pressure and improve lipid metabolism. Sleeve gastrectomy can improve the level of blood glucose and serum lipid of type 2 diabetic rats by ameliorate insulin level and insulin resistance, which may be related with the change of gastrointestinal hormones such as ghrelin and GLP-1. So, intervention of gastrointestinal tract and gastrointestinal hormone secretion may be a new therapy for glycolipids disorder and vascular complications. But, it is lack of evidence-based medicine proof on the relationship between prokinetic drug and glycolipids metabolism. So, the investigators designed a prospective, randomized, double-blinded, placebo control study, and try to evaluate the effects of prokinetic drug (Mosapride) on the blood glucose and serum lipid in type 2 diabetic patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Mosapride Mosapride(5mg, 3/d), antidiabetic drug except DPP-IV inhibitor and GLP-1 receptor activator. |
Drug: Mosapride
Mosapride(5mg, 3/d), antidiabetic drug except DPP-IV inhibitor and GLP-1 receptor activator.
|
| Placebo Comparator: Placebo Placebo(5mg, 3/d), antidiabetic drug except DPP-IV inhibitor and GLP-1 receptor activator. |
Drug: Placebo
Placebo(5mg, 3/d), antidiabetic drug except DPP-IV inhibitor and GLP-1 receptor activator.
|
Outcome Measures
Primary Outcome Measures
- Change of fasting plasma glucose (FPG,mmol/L) [Baseline, 24weeks (End of Trial)]
- Change of OGTT 2 hour blood glucose(mmol/L) [Baseline, 24weeks (End of Trial)]
- Change of HbA1c(%) [Baseline, 24weeks (End of Trial)]
- Change of control rate of blood glucose(%) [Baseline, 24weeks (End of Trial)]
Secondary Outcome Measures
- Change of insulin release(uU/mL) [Baseline, 24weeks (End of Trial)]
- Change of C peptide release(nmol/L) [Baseline, 24weeks (End of Trial)]
- Change of HOMA-β[HOMA-β=20×（FINS,mIU/L）/（（FPG,mmol/L）-3.5）] [Baseline, 24weeks (End of Trial)]
- Change of HOMA-IR [HOMA-IR=(FPG,mmol/L）×（FINS,mIU/L）/22.5] [Baseline, 24weeks (End of Trial)]
- Change of blood glucose variability(%) [Baseline, 24weeks (End of Trial)]
- Change of triglyceride(mmol/L） [Baseline, 24weeks (End of Trial)]
- Change of total cholesterol(mmol/L） [Baseline, 24weeks (End of Trial)]
- Change of LDL-c(mmol/L） [Baseline, 24weeks (End of Trial)]
- Change of HDL-c(mmol/L） [Baseline, 24weeks (End of Trial)]
- Change of Glucagon(pg/ml). [Baseline, 24weeks (End of Trial)]
- Change of GLP(pg/ml). [Baseline, 24weeks (End of Trial)]
- Change of GIP(pg/ml). [Baseline, 24weeks (End of Trial)]
- Change of DPP-IV(pg/ml). [Baseline, 24weeks (End of Trial)]
- Change of waist circumference (WC,cm) [Baseline, 24weeks (End of Trial)]
- Change of body mass index (BMI=weight(kg)/[height(m)2], kg/m2) [Baseline, 24weeks (End of Trial)]
- Change of body fat(%). [Baseline, 24weeks (End of Trial)]
- Change of carotid intima-media thickness (IMT,mm). [Baseline, 24weeks (End of Trial)]
- Change of 24-hours urine sodium(mmol/24h) [Baseline, 24weeks (End of Trial)]
- Change of 24-hours microalbumin(mg/L). [Baseline, 24weeks (End of Trial)]
- Change of 24-hours mALB/Cr(mg/g.Cr). [Baseline, 24weeks (End of Trial)]
- Change of inflammatory markers(hs-CRP,mg/L). [Baseline, 24weeks (End of Trial)]
- Incidence rate of newly-diagnosed hypertension(%). [Baseline, 24weeks (End of Trial)]
- Heart rate variability(HRV,%). [Baseline, 24weeks (End of Trial)]
- Change of clinic blood pressure and 24h mean blood pressure(mmHg). [Baseline, 24weeks (End of Trial)]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male or female, age between 30-65 years old
-
Type 2 diabetes
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Duration of diabetes less than 5 years and pancreatic function be in compensated stage.
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7%≤HbA1C≤9%
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Patients are able to control diet and exercise by themselves in intervention period.
Exclusion Criteria:
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Type 2 diabetes with serious complications, such as diabetic neuropathy, diabetic retinopathy, stage IV diabetic nephropathy, or acute diabetic complications.
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Type 2 diabetes using insulin, GLP-1 analogues or DPP-IV inhibitors).
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Heart function in NYHA Grade II-IV or history of cardio-cerebral vascular events such as congestive heart failure, myocardial infarction or stroke within 3 months.
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Hypohepatia (AST or ALT is two times higher than the upper limit) or history of cirrhosis, hepatic encephalopathy, esophageal varices or portal shunt.
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Renal insufficiency ( serum creatinine is 1.5 times higher than the upper limit) or history of dialysis and nephritic syndrome.
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Chronic obstructive pulmonary disease (COPD), chronic respiratory failure or hyoxemia.
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Acute infections, tumor, severe arrhythmia, mental disorders, alcohol or medicine addiction.
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Fertile woman without contraceptives.
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Any surgical or medical conditions that significantly influence absorption, distribution, metabolism or excretion of the intervention drugs.
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Allergic to or have contraindication to the intervention drugs.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Third Military Medical University
Investigators
- Study Director: Zhu Zhiming, MD, PhD, The third hospital affiliated to the Third Military Medical University. China
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PDBG