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Trial record 43 of 159 for:    GLP-1R

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

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ClinicalTrials.gov Identifier: NCT02606617
Recruitment Status : Unknown
Verified November 2015 by Zhiming Zhu, Third Military Medical University.
Recruitment status was:  Not yet recruiting
First Posted : November 17, 2015
Last Update Posted : November 17, 2015
Sponsor:
Information provided by (Responsible Party):
Zhiming Zhu, Third Military Medical University

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
Type 2 Diabetes Drug: Mosapride Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: What is the Effects of Prokinetic Drug on the Blood Glucose in Type 2 Diabetes Patients: Mosapride Comparing Placebo
Study Start Date : December 2015
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

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.




Primary Outcome Measures :
  1. Change of fasting plasma glucose (FPG,mmol/L) [ Time Frame: Baseline, 24weeks (End of Trial) ]
  2. Change of OGTT 2 hour blood glucose(mmol/L) [ Time Frame: Baseline, 24weeks (End of Trial) ]
  3. Change of HbA1c(%) [ Time Frame: Baseline, 24weeks (End of Trial) ]
  4. Change of control rate of blood glucose(%) [ Time Frame: Baseline, 24weeks (End of Trial) ]

Secondary Outcome Measures :
  1. Change of insulin release(uU/mL) [ Time Frame: Baseline, 24weeks (End of Trial) ]
  2. Change of C peptide release(nmol/L) [ Time Frame: Baseline, 24weeks (End of Trial) ]
  3. Change of HOMA-β[HOMA-β=20×(FINS,mIU/L)/((FPG,mmol/L)-3.5)] [ Time Frame: Baseline, 24weeks (End of Trial) ]
  4. Change of HOMA-IR [HOMA-IR=(FPG,mmol/L)×(FINS,mIU/L)/22.5] [ Time Frame: Baseline, 24weeks (End of Trial) ]
  5. Change of blood glucose variability(%) [ Time Frame: Baseline, 24weeks (End of Trial) ]
  6. Change of triglyceride(mmol/L) [ Time Frame: Baseline, 24weeks (End of Trial) ]
  7. Change of total cholesterol(mmol/L) [ Time Frame: Baseline, 24weeks (End of Trial) ]
  8. Change of LDL-c(mmol/L) [ Time Frame: Baseline, 24weeks (End of Trial) ]
  9. Change of HDL-c(mmol/L) [ Time Frame: Baseline, 24weeks (End of Trial) ]
  10. Change of Glucagon(pg/ml). [ Time Frame: Baseline, 24weeks (End of Trial) ]
  11. Change of GLP(pg/ml). [ Time Frame: Baseline, 24weeks (End of Trial) ]
  12. Change of GIP(pg/ml). [ Time Frame: Baseline, 24weeks (End of Trial) ]
  13. Change of DPP-IV(pg/ml). [ Time Frame: Baseline, 24weeks (End of Trial) ]
  14. Change of waist circumference (WC,cm) [ Time Frame: Baseline, 24weeks (End of Trial) ]
  15. Change of body mass index (BMI=weight(kg)/[height(m)2], kg/m2) [ Time Frame: Baseline, 24weeks (End of Trial) ]
  16. Change of body fat(%). [ Time Frame: Baseline, 24weeks (End of Trial) ]
  17. Change of carotid intima-media thickness (IMT,mm). [ Time Frame: Baseline, 24weeks (End of Trial) ]
  18. Change of 24-hours urine sodium(mmol/24h) [ Time Frame: Baseline, 24weeks (End of Trial) ]
  19. Change of 24-hours microalbumin(mg/L). [ Time Frame: Baseline, 24weeks (End of Trial) ]
  20. Change of 24-hours mALB/Cr(mg/g.Cr). [ Time Frame: Baseline, 24weeks (End of Trial) ]
  21. Change of inflammatory markers(hs-CRP,mg/L). [ Time Frame: Baseline, 24weeks (End of Trial) ]
  22. Incidence rate of newly-diagnosed hypertension(%). [ Time Frame: Baseline, 24weeks (End of Trial) ]
  23. Heart rate variability(HRV,%). [ Time Frame: Baseline, 24weeks (End of Trial) ]
  24. Change of clinic blood pressure and 24h mean blood pressure(mmHg). [ Time Frame: Baseline, 24weeks (End of Trial) ]


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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  • 7%≤HbA1C≤9%
  • Patients are able to control diet and exercise by themselves in intervention period.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02606617


Contacts
Contact: Zhu Zhiming, MD, PhD 86-023-68767849 zhuzm@yahoo.com
Contact: Zhong Jian, MD 86-023-68757883 zhongjian2000@21cn.com

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

Responsible Party: Zhiming Zhu, MD, PhD, Third Military Medical University
ClinicalTrials.gov Identifier: NCT02606617     History of Changes
Other Study ID Numbers: PDBG
First Posted: November 17, 2015    Key Record Dates
Last Update Posted: November 17, 2015
Last Verified: November 2015

Keywords provided by Zhiming Zhu, Third Military Medical University:
Mosapride
blood glucose
serum lipid

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Mosapride
Physiological Effects of Drugs
Gastrointestinal Agents
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action