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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01758471
Recruitment Status : Unknown
Verified December 2012 by Guang Ning, Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Recruiting
First Posted : January 1, 2013
Last Update Posted : January 1, 2013
Information provided by (Responsible Party):
Guang Ning, Shanghai Jiao Tong University School of Medicine

Brief Summary:
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 or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Glipizide Drug: Acarbose Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : December 2012
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. euglycemia [ Time Frame: 3 months ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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 identifier (NCT number): NCT01758471

Contact: Guang Ning, M.D. Ph.D. 86-021-64370045 ext 665344
Contact: Yanyun Gu, M.D. Ph.D. 86-021-64370045 ext 663325

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
Principal Investigator: Guang Ning, M.D. Ph.D. Shanghai Jiao Tong University School of Medicine

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 Identifier: NCT01758471     History of Changes
Other Study ID Numbers: CCEMD017
First Posted: January 1, 2013    Key Record Dates
Last Update Posted: January 1, 2013
Last Verified: December 2012

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

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