Observational Study of Drug Naive Diabetes Receiving Insulin Therapy

Observational Study of Drug Naive Type 2 Diabetes Receiving Continuous Subcutaneous Insulin Infusion Therapy

A multi-centre, open-label trial to investigate the efficacy and possible mechanism of Continuous Subcutaneous Insulin Infusion treatment in patients with drug naive type 2 diabetes.

Study Overview

• Status: Unknown
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: Insulin

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Recruiting
      • at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • Zhejiang Provincial People's Hospital
      • Contact: xiao ye, MD; Phone Number: 86-571-85893937
      • Principal Investigator: xiao ye, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

drug naive type 2 diabetes and healthy controls

Description

Inclusion Criteria:

for type 2 diabetes:

1. Male or female age ≧ 25 years and ≦75 years old
2. HbA1c ≧8.0%
3. durg naive

for normal controls：

1. Male or female age ≧ 25 years and ≦75 years old
2. Normal glucose tolerance confirmed by oral glucose tolerance test

Exclusion Criteria:

1. Islet antibody positive
2. Athletes, has a history of skeletal muscle injury ( trauma or surgery ), skeletal muscle wasting diseases ( such as mitochondrial myopathy, muscular atrophy, etc )
3. Acute infection(such as cute upper respiratory infection, acute pneumonia)
4. long-term use of non-steroidal anti-inflammatory drugs, corticosteroids and immunosuppressive drugs
5. consists with other endocrine diseases
6. pregnancy
7. cancer
8. use of antibiotics in 3 months
9. chronic digestive inflammations
10. magnetic resonance imaging contraindications

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Type 2 Diabetes; drug naive Type 2 Diabetes received insulin therapy	Drug: Insulin; Continuous Subcutaneous Insulin Infusion
normal control; healthy volunteers as normal control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Circulating immunity cell profiles	profiles of circulating immunity cells such as T cells	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
skeletal muscle parameter	skeletal muscle parameters in magnetic resonance imaging	7 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
fasting blood glucose	fasting blood glucose	7 days

Collaborators and Investigators

• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Collaborators: Zhejiang Provincial People's Hospital

Publications and helpful links

General Publications

• Zhang W, Wang H, Liu F, Ye X, Tang W, Zhang P, Gu T, Zhu D, Bi Y. Effects of Early Intensive Insulin Therapy on Endothelial Progenitor Cells in Patients with Newly Diagnosed Type 2 Diabetes. Diabetes Ther. 2022 Apr;13(4):679-690. doi: 10.1007/s13300-021-01185-w. Epub 2021 Dec 11. Erratum In: Diabetes Ther. 2022 Mar 14;:
• Tang W, Zhang B, Wang H, Li M, Wang H, Liu F, Zhu D, Bi Y. Improved skeletal muscle energy metabolism relates to the recovery of beta cell function by intensive insulin therapy in drug naive type 2 diabetes. Diabetes Metab Res Rev. 2019 Oct;35(7):e3177. doi: 10.1002/dmrr.3177. Epub 2019 May 27.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Anticipated): August 30, 2020
• Study Completion (Anticipated): August 30, 2021

Study Registration Dates

• First Submitted: October 15, 2018
• First Submitted That Met QC Criteria: October 17, 2018
• First Posted (Actual): October 18, 2018

Study Record Updates

• Last Update Posted (Actual): October 18, 2018
• Last Update Submitted That Met QC Criteria: October 17, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: insulin; drug naive
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: INSULIN001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: no plan to share

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No