Type 2 Diabetes Clinical Trial
Official title:
The Acute Effect of a Low-carbohydrate Meal on the Plasma Fatty Acid Composition in Patients With Type 2 Diabetes
The investigators wishes to investigate the acute effect of a low carbohydrate meal on the plasma fatty acid (FA) composition compared with a control meal in a cross-over study of patients with type 2 diabetes (T2D). In two trial days 12 participants with T2D will either have a low carbohydrate meal or control meal, measurements will be performed at baseline and continuously over 5 hours.
Status | Recruiting |
Enrollment | 12 |
Est. completion date | December 2022 |
Est. primary completion date | December 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Duration of established type 2 diabetes for more than six months and less than five years, but duration of type 2 diabetes for up to 10 years if the current treatment consists of = 2 oral antidiabetic drugs without insulin. 2. HbA1c in compliance with type 2 diabetes (above 48 mmol/mol), with or without use of glucose-lowering pharmacotherapy, but without need for adjustment of antidiabetic treatment. 3. Stable antidiabetic treatment three months prior to inclusion. 4. Well treated dyslipidemia (LDL cholesterol < 2.5 mmol/l and total cholesterol < 4.5 mmol/l at inclusion) with or without statins. 5. BMI = 25. 6. Age = 18 years. 7. All participants have to understand oral and written Danish. 8. All participants have to sign an informed consent after oral and written information on experimental design. Exclusion Criteria: 1. Significant comorbidity, including liver disease. 2. A history of cancer < 5 years or current chemotherapy. 3. Other severe co-morbidity that could interfere with study compliance or safety (e.g. previous gastrointestinal operations, liver disease, history of eating disorder, current alcohol overuse or hypoglycemic unawareness). 4. Current treatment with glucocorticoids (systemic). 5. Continuous treatment with steatosis-inducing drugs. 6. Treatment with antibiotics during the last two months before inclusion. 7. Low-carbohydrate diet prior to inclusion, or other restrictive diet. 8. Weight-loss > 10 kg over the last three months before inclusion. 9. Pregnancy or expected pregnancy within the next 6 months. 10. Elevated blood pressure (180/110) with or without antihypertensives. |
Country | Name | City | State |
---|---|---|---|
Denmark | Odense University Hospital | Odense |
Lead Sponsor | Collaborator |
---|---|
Odense University Hospital | Aalborg University Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Plasma fatty acid composition | Quantified as weight percentage (wt%) of total plasma phospholipid FA | 5 hours | |
Secondary | Plasma glucose | 5 hours | ||
Secondary | Serum insulin | 5 hours | ||
Secondary | Plasma ketones | 5 hours | ||
Secondary | Plasma free fatty acid | 5 hours | ||
Secondary | Total cholesterol | 5 hours | ||
Secondary | LDL cholesterol | 5 hours | ||
Secondary | HDL cholesterol | 5 hours | ||
Secondary | Triglycerides | 5 hours | ||
Secondary | Other lipoprotein fractions | 5 hours | ||
Secondary | Glucagon Like Peptide 1 (GLP1) | 5 hours | ||
Secondary | Glucose-Dependent Insulinotropic Polypeptide (GIP) | 5 hours | ||
Secondary | Cholecystokinin (CCK) | 5 hours | ||
Secondary | Peptide YY (PYY) | 5 hours | ||
Secondary | Ghrelin | 5 hours | ||
Secondary | Subjective appetite | Visual analog scale - mm. 0 mm - 100 mm. 0 mm = none and 100 mm = very strong | 5 hours |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05219994 -
Targeting the Carotid Bodies to Reduce Disease Risk Along the Diabetes Continuum
|
N/A | |
Completed |
NCT04056208 -
Pistachios Blood Sugar Control, Heart and Gut Health
|
Phase 2 | |
Completed |
NCT02284893 -
Study to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone
|
Phase 3 | |
Completed |
NCT04274660 -
Evaluation of Diabetes and WELLbeing Programme
|
N/A | |
Active, not recruiting |
NCT05887817 -
Effects of Finerenone on Vascular Stiffness and Cardiorenal Biomarkers in T2D and CKD (FIVE-STAR)
|
Phase 4 | |
Active, not recruiting |
NCT05566847 -
Overcoming Therapeutic Inertia Among Adults Recently Diagnosed With Type 2 Diabetes
|
N/A | |
Recruiting |
NCT06007404 -
Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
|
||
Completed |
NCT04965506 -
A Study of IBI362 in Chinese Patients With Type 2 Diabetes
|
Phase 2 | |
Recruiting |
NCT06115265 -
Ketogenic Diet and Diabetes Demonstration Project
|
N/A | |
Active, not recruiting |
NCT03982381 -
SGLT2 Inhibitor or Metformin as Standard Treatment of Early Stage Type 2 Diabetes
|
Phase 4 | |
Completed |
NCT04971317 -
The Influence of Simple, Low-Cost Chemistry Intervention Videos: A Randomized Trial of Children's Preferences for Sugar-Sweetened Beverages
|
N/A | |
Completed |
NCT04496154 -
Omega-3 to Reduce Diabetes Risk in Subjects With High Number of Particles That Carry "Bad Cholesterol" in the Blood
|
N/A | |
Completed |
NCT04023539 -
Effect of Cinnamomum Zeylanicum on Glycemic Levels of Adult Patients With Type 2 Diabetes
|
N/A | |
Recruiting |
NCT05572814 -
Transform: Teaching, Technology, and Teams
|
N/A | |
Enrolling by invitation |
NCT05530356 -
Renal Hemodynamics, Energetics and Insulin Resistance: A Follow-up Study
|
||
Completed |
NCT04097600 -
A Research Study Comparing Active Drug in the Blood in Healthy Participants Following Dosing of the Current and a New Formulation (D) Semaglutide Tablets
|
Phase 1 | |
Completed |
NCT03960424 -
Diabetes Management Program for Hispanic/Latino
|
N/A | |
Completed |
NCT05378282 -
Identification of Diabetic Nephropathy Biomarkers Through Transcriptomics
|
||
Active, not recruiting |
NCT06010004 -
A Long-term Safety Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes
|
Phase 3 | |
Completed |
NCT03653091 -
Safety & Effectiveness of Duodenal Mucosal Resurfacing (DMR) Using the Revita™ System in Treatment of Type 2 Diabetes
|
N/A |