Efficacy of Acarbose on Intestinal Microbiome and Incretins of Type 2 Diabetes

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Shanghai Jiao Tong University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Guang Ning, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT01758471
First received: December 24, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  Purpose

This study is aimed to investigate the effect of acarbose on intestinal microbiome and incretins, therefore to explore the new pathways or new targets to treat type 2 diabetes.


Condition Intervention Phase
Type 2 Diabetes
Drug: Glipizide
Drug: Acarbose
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: An Open-label, Randomized , Phase 4 Study to Compare the Different Efficacies of α-glucosidase Inhibitor and Sulfonylurea on Improvement of Intestinal Microbiome and Serum Incretins in Patients With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • euglycemia [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: December 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acarbose
The minimum dosage of acarbose in this study is 100mg tid p.o.(oral) for 3 month. With this dosage, patients should have similar glycemic control with those using glipizide, that is FBG(fasting blood glucose)<7.0,PBG(postprandial blood glucose)<10.0
Drug: Acarbose
Acarbose 50mg per pill 100mg to 150mgtid p.o.(oral) for 3 month
Other Name: glucobay
Active Comparator: glipizide
There is no fixed dosage of glipizide to control hyperglycemia for patients in this group. As long as the targeted blood glucose concentration is reached, FBG< 7.0, PBG< 10.0, patients will have the least dosage of glipizide according to their glucose level.
Drug: Glipizide
glipizide 5mg per pill 5mg tid p.o. for 3 month

Detailed Description:

In recent years, Endocrinologist and Diabetologists have found that intestine might serve as a novel target for treating diabetes or other metabolic diseases. Incretins are well-known hormones secreted from intestine, such as CCK(Cholecystokinin), Serotonin, GIP(gastric inhibitory polypeptide) and GLP-1(glucagon like peptide 1), to help control wholesome metabolic status through their effects on pancreatic islet cells, hypothalamus neurons and gastrointestinal movement. Gut microbiome has been recently revealed exerting major effect on host's immune system and metabolic balance with its various metabolites and components.

α-glucosidase inhibitors have been used as anti-diabetes medicine for dozens of years. They are known to be effective by delaying glucose absorption in small intestine. Questions then have been arisen that if delaying glucose absorption changes the intestinal bacteria flora component by increasing bacteria fed on glucose, or that if it influences incretin secretion, since most glucose sensitive L cell (secreting GLP-1) were located in the distal part of small intestine and colon, and that if the hypoglycemia effect of α-glucosidase inhibitors might be mediated by either intestinal flora or incretins.

To address the questions above and to find the new targets from the intestine to treat diabetes, we therefore design this study, taking advantage of clinical trial and basic biomedical studies to find if α-glucosidase inhibitor- Acarbose (Bayer, Corp.) could change the profile of intestinal incretins and microbiome.

Study design:

  1. Multi-center, open label, randomized, positive control cohort.
  2. 110 cases of newly-diagnosed Type-2 Diabetes patients from five clinic centers from Shanghai, China Mainland.
  3. All patients will sign the consent and screened by the criteria before enrolled by this study.
  4. 55 cases of Type 2 Diabetes will be assigned to glucobay treatment and another 55 will take glipizide.
  5. 50 healthy volunteers for baseline data comparison.
  6. The duration of whole study will be 3 month.

    1. Before treatment, all the patients will be required to have OGTT(oral glucose tolerant test) and IRT(insulin release test) test and give their feces. Standard meals will be required one day before the feces are collected.
    2. In 3 months, all patients will take the medicine and their glucose will be monitored closely by visiting outpatient office once a month.
    3. In the end of the study, patients will be required to receive OGTT and IRT and give their feces again.
  7. Serum and feces will be stored at -80℃ for further biomarkers investigation and microbiome sequencing.
  8. After 3 months intervention, patients will be observed for another 3 month with access to routine clinic visiting.
  Eligibility

Ages Eligible for Study:   40 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Newly diagnosed Type 2 Diabetes, without any previous drug treatment,
  • 7.0 mmol/l <=FBG<=13.O mmol/l, HbA1C <=10%
  • Body mass index (BMI) < 35kg/m2 (inclusive);
  • Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted
  • Having good study compliance

Exclusion Criteria:

  • Intestinal surgery or recent abdominal surgery within 1 year
  • Taken immunosuppressive agents, steroid,antidiarrhea agents, antibiotics and other gastrointestinal motility agents within 3 months
  • Severe liver dysfunction, including serum alanine aminotransferase concentration more than 2.5 times above upper limit of normal range, abnormal renal function (GFR < 60ml/min)
  • Other severe conditions which will put the patients in high risk during the study
  • Any clinically significant allergic disease
  • Women in pregnancy or under breast feeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01758471

Contacts
Contact: Guang Ning, M.D. Ph.D. 86-021-64370045 ext 665344 guangning@medmail.com.cn
Contact: Yanyun Gu, M.D. Ph.D. 86-021-64370045 ext 663325 guyanyun@hotmail.com

Locations
China, Shanghai
Shanghai Clinic Center for Endocrine and Metabolic Diseases, Ruijin Hospital, Shanghai Institute for Endocrine and Metabolic Diseases Recruiting
Shanghai, Shanghai, China, 200025
Contact: Guang Ning, M.D.    86-021-64370045 ext 665344      
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
Principal Investigator: Guang Ning, M.D. Ph.D. Shanghai Jiao Tong University School of Medicine
  More Information

No publications provided

Responsible Party: Guang Ning, Vice president of Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine, Director of Shanghai Institute for Endocrine and Metabolic Diseases, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT01758471     History of Changes
Other Study ID Numbers: CCEMD017
Study First Received: December 24, 2012
Last Updated: December 24, 2012
Health Authority: China: Ethics Committee

Keywords provided by Shanghai Jiao Tong University School of Medicine:
Type 2 Diabetes
gut microbiome
incretin
Sulfonylurea
α-glucosidase inhibitor

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Acarbose
Glipizide
Incretins
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 16, 2014