The Impact of Glucotoxicity on Gastric Emptying in Chinese Patients With Newly Diagnosed Type 2 Diabetes

NCT05284344 | Completed

• 1 other identifier: KY20220214-08
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

Gastric emptying is now recognized as a major determinant of the blood glucose response to carbohydrate in both health and type 2 diabetes (T2D). While patients with longstanding diabetes exhibit a high prevalence of delayed gastric emptying, i.e. gastroparesis, patients with fewer complications are often associated with accelerated gastric emptying, which exacerbates postprandial glycaemic excursions. Moreover, gastric emptying appears to be more rapid in Han Chinese patients with T2D, as compared to Caucasian patients with T2D. The proposed study will (i) compare the rate of gastric emptying in newly diagnosed, Chinese patients with T2D to non-diabetic controls, (ii) evaluate the relationship between gastric emptying and glycaemic indices, including measures of glucose variability, and (iii) determine whether gastric emptying is altered by glucose-lowering therapies.

Conditions

Type 2 Diabetes

Keywords

type 2 diabetes; gastric emptying; gut hormones; blood glucose; bile acid; glycaemia variability

Outcome Measures

Primary Outcomes (2)

• Change in Gastric-half emptying time of the 75 g glucose drink

  The Change in gastric-half emptying time (min) before and after the treatment

  Baseline, 1 month and 3 months in diabetic group

• Gastric-half emptying time of the 75 g glucose drink

  The difference in gastric-half emptying time (min) between subjects with and without type 2 diabetes

  Baseline in both diabetic and non-diabetic group

Secondary Outcomes (11)

• The mean blood glucose level

  Baseline, 1 month and 3 months in the diabetic group

• The mean amplitude of glycemic excursion

  Baseline, 1 month and 3 months in the diabetic group

• The percentage of blood glucose levels within the target range

  Baseline, 1 month and 3 months in the diabetic group

• Serum insulin concentrations

  t = 0, 30, 60, 120 and 180 min (t = 0 is when 75 g glucose drink is given) on baseline, 1 month and 3 months in the diabetic group

• Serum C-peptide concentrations

  t = 0, 30, 60, 120 and 180 min (t = 0 is when 75 g glucose drink is given) on baseline, 1 month and 3 months in the diabetic group

Study Arms (2)

patients with newly diagnosed type 2 diabetes

Newly diagnosed, drug-naïve, Chinese patients with type 2 diabetes.

Drug: Anti-Diabetics

Non-diabetic control subjects

Interventions

Anti-Diabetics DRUG

The anti-diabetic treatments include insulin glargine, insulin aspart, GLP-1 receptor agonist, DPP-4 inhibitor, SGLT-2 inhibitor, metformin, sulfonylureas and/or gliclazide. Therapeutic dose of each drug follows recommendation by the treating doctor.

patients with newly diagnosed type 2 diabetes

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Han Chinese patients newly diagnosed type 2 diabetes Han Chinese non-diabetic subjects

You may qualify if:

• Patients newly diagnosed of type 2 diabetes as defined by published Criteria of World Health Organization in 1999; with HbA1c ≥ 7%, age ≥ 18 years of age and ≤ 80 years old, and willing to receive anti-diabetic treatments,
• Non-diabetic controls, with BMI and age matched to patients with type 2 diabetes

You may not qualify if:

• Patients with a fasting blood glucose ≤ 3.9mmol/L;
• Patients with insulin allergy;
• Patients with severe gastrointestinal symptoms and diseases;
• Patients with gastrointestinal surgery history;
• Use of any medication that may influence gastrointestinal motor function, body weight or appetite (opiates, anticholinergics, levodopa, clonidine, nitrates, tricyclic antidepressants, selective serotonin re-uptake inhibitors, phosphodiesterase type 5 inhibitors, sumatriptan, metoclopramide, domperidone, cisapride, prucalopride, or erythromycin);
• Patients with major cardiovascular disease event (e.g., stroke, symptomatic peripheral artery disease, myocardial infarction, percutaneous coronary or peripheral artery angioplasty or coronary artery bypass surgery) in the previous 6 months;
• Patients with liver dysfunction (aspartate aminotransferase or alanine aminotransferase level of more than two times the upper limit of normal range) or renal dysfunction (creatinine \> 150 μmol/L or GFR \< 60 mL/min/1.73m2);
• Patients with severe anemia and hemoglobin disorders (Hb \< 60 g/L);
• Patients with infected injection site or coagulation disorders;
• Patients who are pregnant.

Sponsors & Collaborators

• University of Adelaide: lead
• The First Affiliated Hospital with Nanjing Medical University: collaborator

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210000, China

Location

Related Publications (5)

• Xie C, Huang W, Wang X, Trahair LG, Pham HT, Marathe CS, Young RL, Jones KL, Horowitz M, Rayner CK, Wu T. Gastric emptying in health and type 2 diabetes: An evaluation using a 75 g oral glucose drink. Diabetes Res Clin Pract. 2021 Jan;171:108610. doi: 10.1016/j.diabres.2020.108610. Epub 2020 Dec 7.

  PMID: 33301790 BACKGROUND

• Wang X, Xie C, Marathe CS, Malbert CH, Horowitz M, Jones KL, Rayner CK, Sun Z, Wu T. Disparities in gastric emptying and postprandial glycaemia between Han Chinese and Caucasians with type 2 diabetes. Diabetes Res Clin Pract. 2020 Jan;159:107951. doi: 10.1016/j.diabres.2019.107951. Epub 2019 Nov 29.

  PMID: 31790715 BACKGROUND

• Goyal RK. Gastric Emptying Abnormalities in Diabetes Mellitus. N Engl J Med. 2021 May 6;384(18):1742-1751. doi: 10.1056/NEJMra2020927. No abstract available.

  PMID: 33951363 BACKGROUND

• Watson LE, Xie C, Wang X, Li Z, Phillips LK, Sun Z, Jones KL, Horowitz M, Rayner CK, Wu T. Gastric Emptying in Patients With Well-Controlled Type 2 Diabetes Compared With Young and Older Control Subjects Without Diabetes. J Clin Endocrinol Metab. 2019 Aug 1;104(8):3311-3319. doi: 10.1210/jc.2018-02736.

  PMID: 30933282 BACKGROUND

• Phillips LK, Deane AM, Jones KL, Rayner CK, Horowitz M. Gastric emptying and glycaemia in health and diabetes mellitus. Nat Rev Endocrinol. 2015 Feb;11(2):112-28. doi: 10.1038/nrendo.2014.202. Epub 2014 Nov 25.

  PMID: 25421372 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Hypoglycemic Agents

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Tongzhi Wu, PhD

  The University of Adelaide

  PRINCIPAL INVESTIGATOR

• Jianhua Ma, PhD

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 24, 2022
• First Posted: March 17, 2022
• Study Start: January 24, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)