Type 2 diabetes (T2DM) patients with oral anti-diabetic drugs (OAD) losing efficacy Nutritional, Metabolic, Endocrine
Conditions
Interventions
1. 30 patients with OAD losing efficacy receiving insulin plus metformin
2. 30 patients with OAD losing efficacy receiving insulin monotherapy
Intervention was for 16 weeks.
Sponsors
Qilu Hospital, Shandong University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosed with T2DM 2. Treated with two or more OADs for more than three months with blood glucose HbA1c=7% within 14 days of the screening day 3. Aged between 18 to 79 4. BMI=18.5kg/m2 5. According to investigators’ judgment, subjects are able and willing to obey the following instructions: 5.1. During the whole study, treatment will be continued according to the requirements in the protocol 5.2. During the whole study, diet will be maintained according to the requirements in the protocol 5.3. Participation in regular visits, and willing to receive telephone follow-up 5.4. Women that are able to conceive (and men whose partner can conceive) are willing to be given contraceptive treatment during the whole study 6. Participants must be male, or non-pregnant females who are not breastfeeding 7. Participants must be without metformin contraindications 8. All participants must sign informed consent form before any study relevant activities have been conducted
Exclusion criteria
Exclusion criteria: 1. Participants diagnosed with type 1 diabetes 2. Previously treated with insulin for more than 14 days continuously within 3 months before screening visit or within one month before the patient entering the study 3. Diagnosed with any of the following cardiovascular diseases within three months before screening visit: acute myocardial infarction, heart function classification III/IV according to New York Heart Association, congestive heart failure with left ventricular ejection fraction = 40%, or cerebrovascular events (apoplexy) 4. Impaired liver function, with obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or ALT/AST levels =2.0 times of the upper limit of the reference range at the screening visit 5. Serum creatinine =1.5mg/dl (133 µmol/L) for men, =1.4mg/dl (124 µmol/L) for womenor eGFR14 days) systemic glucocorticoid treatment (external use, intraocular, inhaled or intranasal preparations except) or received this type of treatment within four weeks before screening visit; During the whole study, any treatment which can affect glucose regulation should be avoided, as thyroid medication, estrogen, oral contraceptives, phenytoin, niacin, sympathomimetic drugs and isoniazid 12. Hematological system diseases which maybe affect HbA1c value (as hemolytic anemia, sickle cell disease) 13. Any conditions which may affect patients follow and complete the study protocol (as known drug abuse, alcoholic, mental diseases) 14. Currently in a study or 30 days before recruiting withdrawing from a study which involves the investigational medicinal product or not approved drugs or instruments; or participating other types of clinical studies at the same time and not suitable to participate in this study judged by investigators from medical or science perspectives 15. Allergic to metformin/insulin or with metformin/insulin contraindication 16. Combined with severe lung diseases or history of hypoxia 17. Combined with endocrine diseases as hypercortisolism; patients with thyroid diseases under control of drugs for more than half year can be included; 18. Stress state as surgery, acute craniocerebral injury etc 19. Vitamin B12 deficiency without correction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Identifying the change of composition of gut microbiota by 16s rRNA technology Measured once a month over the study period. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Achievement of HbA1c 2. Achievement of weight loss 3. Change in HbA1c 4. Waist circumference 5. Fasting blood glucose 6. Lipids and CRP 7. LPS,IL-6mRNA,IL-1BmRNA,CD4/CD8 and Foxp3Tre They will be measured once a month. | — |
Countries
China
Outcome results
None listed