Type 2 Diabetes Mellitus Clinical Trial
Official title:
Fish Oil-derived Omega-3 Fatty Acids on Gut Microbiota and Lipid Metabolome in Type 2 Diabetes Mellitus: a Randomized, Double-blind, Placebo-Controlled Clinical Trial
Verified date | November 2023 |
Source | Southeast University, China |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective of this research was to investigate the impact of Omega-3 PUFAs on the gut microbiota and serum lipid metabolites in participants diagnosed with type 2 diabetes, employing high-throughput sequencing technology and untargeted lipidomics.
Status | Completed |
Enrollment | 110 |
Est. completion date | January 31, 2020 |
Est. primary completion date | August 29, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - Patients with type 2 diabetes have been diagnosed; - Male or female aged 18-70 years; - After listening to the project presentation, voluntarily participate in the study and sign an informed consent form. Exclusion Criteria: - Pregnant or lactating women; - Poorly controlled diabetes, i.e. HbA1c>9%; - Have taken omega-3 PUFAs-related supplements in the past six months; - Taking lipid-lowering drugs or other drugs that affect blood lipid metabolism; - Patients with severe diabetic complications, severe hypertension, combined with - diseases of the heart, brain, liver, kidney, thyroid and hematopoietic system, psychosis; - Patients with severe immune system disorders; - Have special diets: vegetarians, weight managers, ketogenic test takers, etc; - The attending physician deems the participant unsuitable |
Country | Name | City | State |
---|---|---|---|
China | Southeast university | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Southeast University, China | The First Affiliated Hospital with Nanjing Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Concentration of Serum triglycerides | physiological parameter | 12 weeks | |
Primary | Concentration of total cholesterol | physiological parameter | 12 weeks | |
Primary | Concentration of low-density lipoprotein cholesterol | physiological parameter | 12 weeks | |
Primary | Concentration of high-density lipoprotein cholesterol | physiological parameter | 12 weeks | |
Primary | weight in kilograms | physiological parameter | 12 weeks | |
Primary | height in meters | physiological parameter | 12 weeks | |
Primary | body mass index (BMI) | BMI=weight(kg)/height^2(m) | 12 weeks | |
Primary | waist circumference | physiological parameter | 12 weeks | |
Primary | hip measurement | physiological parameter | 12 weeks | |
Primary | Systolic blood pressure | physiological parameter | 12 weeks | |
Primary | Diastolic blood pressure | physiological parameter | 12 weeks | |
Secondary | Number of Participants who take drugs | This indicator refers to the number of participants taking medication. | 12 weeks | |
Secondary | Incidence of diabetes complications | This indicator refers to the proportion of participants experiencing complications from diabetes. | 12 weeks | |
Secondary | Rate of smoking among participants | This indicator refers to the proportion of participants who smoke. | 12 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02771093 -
An Exploratory Study of the Effects of Trelagliptin and Alogliptin on Glucose Variability in Patients With Type 2 Diabetes Mellitus
|
Phase 4 | |
Completed |
NCT02545842 -
Assessment Study of Three Different Fasting Plasma Glucose Targets in Chinese Patients With Type 2 Diabetes Mellitus (BEYOND III/FPG GOAL)
|
Phase 4 | |
Recruiting |
NCT03436212 -
Real-Life Home Glucose Monitoring Over 14 Days in T2D Patients With Intensified Therapy Using Insulin Pump.
|
N/A | |
Completed |
NCT03244800 -
A Study to Investigate Different Doses of 0382 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus.
|
Phase 2 | |
Completed |
NCT03960424 -
Diabetes Management Program for Hispanic/Latino
|
N/A | |
Withdrawn |
NCT02769091 -
A Study in Adult Patients With Nonalcoholic Steatohepatitis Who Also Have Type 2 Diabetes
|
Phase 2 | |
Recruiting |
NCT06065540 -
A Research Study to See How Well CagriSema Compared to Semaglutide, Cagrilintide and Placebo Lowers Blood Sugar and Body Weight in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor
|
Phase 3 | |
Recruiting |
NCT05008276 -
Puberty, Diabetes, and the Kidneys, When Eustress Becomes Distress (PANTHER Study)
|
||
Completed |
NCT04091373 -
A Study Investigating the Pharmacokinetics of a Single Dose Administration of Cotadutide
|
Phase 1 | |
Completed |
NCT03296800 -
Study to Evaluate Effects of Probenecid, Rifampin and Verapamil on Bexagliflozin in Healthy Subjects
|
Phase 1 | |
Recruiting |
NCT06212778 -
Relationship Between Nutritional Status, Hand Grip Strength, and Fatigue in Hospitalized Older Adults With Type 2 Diabetes Mellitus.
|
||
Completed |
NCT05979519 -
Fresh Carts for Mom's to Improve Food Security and Glucose Management
|
N/A | |
Recruiting |
NCT05579314 -
XW014 in Healthy Subjects and Patients With Type 2 Diabetes Mellitus (T2DM)
|
Phase 1 | |
Completed |
NCT03859934 -
Metabolic Effects of Melatonin Treatment
|
Phase 1 | |
Terminated |
NCT03684642 -
Efficacy and Safety of Efpeglenatide Versus Dulaglutide in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin
|
Phase 3 | |
Completed |
NCT03248401 -
Effect of Cilostazol on Carotid Atherosclerosis Estimated by 3D Ultrasound in Patients With Type 2 Diabetes
|
Phase 4 | |
Completed |
NCT03644134 -
A Personalized Intervention to Manage Physiological Stress and Improve Sleep Patterns
|
N/A | |
Completed |
NCT05295160 -
Fasting-Associated Immune-metabolic Remission of Diabetes
|
N/A | |
Completed |
NCT02836873 -
Safety and Efficacy of Bexagliflozin in Type 2 Diabetes Mellitus Patients With Moderate Renal Impairment
|
Phase 3 | |
Completed |
NCT02252224 -
Forxiga (Dapagliflozin) Regulatory Postmarketing Surveillance
|