A Clinical Trial Analyzing Effects of Prokinetic Drug on the Blood Glucose in Patients With Type 2 Diabetes

NCT02606617 | Unknown Phase 4

• 1 other identifier: PDBG
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 2 Diabetes

Keywords

Mosapride; blood glucose; serum lipid

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (24)

• 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)

Study Arms (2)

Mosapride

ACTIVE COMPARATOR

Mosapride(5mg, 3/d), antidiabetic drug except DPP-IV inhibitor and GLP-1 receptor activator.

Drug: Mosapride

Placebo

PLACEBO COMPARATOR

Placebo(5mg, 3/d), antidiabetic drug except DPP-IV inhibitor and GLP-1 receptor activator.

Drug: Placebo

Interventions

Mosapride DRUG

Mosapride(5mg, 3/d), antidiabetic drug except DPP-IV inhibitor and GLP-1 receptor activator.

Mosapride

Placebo DRUG

Placebo(5mg, 3/d), antidiabetic drug except DPP-IV inhibitor and GLP-1 receptor activator.

Placebo

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, age between 30-65 years old
• Type 2 diabetes
• Duration of diabetes less than 5 years and pancreatic function be in compensated stage.
• %≤HbA1C≤9%
• Patients are able to control diet and exercise by themselves in intervention period.

You may not qualify if:

• Type 2 diabetes with serious complications, such as diabetic neuropathy, diabetic retinopathy, stage IV diabetic nephropathy, or acute diabetic complications.
• Type 2 diabetes using insulin, GLP-1 analogues or DPP-IV inhibitors).
• 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.
• Hypohepatia (AST or ALT is two times higher than the upper limit) or history of cirrhosis, hepatic encephalopathy, esophageal varices or portal shunt.
• Renal insufficiency ( serum creatinine is 1.5 times higher than the upper limit) or history of dialysis and nephritic syndrome.
• Chronic obstructive pulmonary disease (COPD), chronic respiratory failure or hyoxemia.
• Acute infections, tumor, severe arrhythmia, mental disorders, alcohol or medicine addiction.
• Fertile woman without contraceptives.
• Any surgical or medical conditions that significantly influence absorption, distribution, metabolism or excretion of the intervention drugs.
• Allergic to or have contraindication to the intervention drugs.

Sponsors & Collaborators

• Third Military Medical University: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

mosapride

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Zhu Zhiming, MD, PhD

  The third hospital affiliated to the Third Military Medical University. China

  STUDY DIRECTOR

Central Study Contacts

Zhu Zhiming, MD, PhD

CONTACT

86-023-68767849; zhuzm@yahoo.com

Zhong Jian, MD

CONTACT

86-023-68757883; zhongjian2000@21cn.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: October 25, 2015
• First Posted: November 17, 2015
• Study Start: December 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2016
• Last Updated: November 17, 2015

Record last verified: 2015-11