Status:
UNKNOWN
Adipose Tissue Dysfunction in Type 2 Diabetes and Its Reversibility by Bariatric Surgery
Lead Sponsor:
Odense University Hospital
Conditions:
Adipose Tissue Dysfunction Type 2 Diabetes Mellitus Bariatric Surgery
Eligibility:
All Genders
30-65 years
Phase:
NA
Brief Summary
ABSTRACT Background: Insulin resistance (IR) plays a major role in the pathogenesis of type 2 diabetes (T2D). Adipose tissue (AT) dysfunction leading to systemic low-grade inflammation and ectopic lip...
Eligibility Criteria
Inclusion
- GAD65 antibody negative patients with T2D
- Treated with either diet alone or diet in combination with metformin, DPP-4 inhibitors, sulphonylureas, GLP1-analogs or insulin (maximum 40 IE long - or intermediate acting insulin).
- HbA1c \< 70 mmol/l for diabetics and \<48 mmol/l for obese.
- Do not have any known diabetic complication (macroalbuminuria, proliferative retinopathy, neuropathy or cardiovascular disease).
- The use of up to two antihypertensive drugs and one cholesterol lowering drug is allowed in patients with T2D and obese individuals.
- Both patients with T2D and obese individuals should be eligible for bariatric surgery, and should be able and willing to discontinue all drugs for 1 week prior to the clamp studies
- Except for the conditions mentioned above, the patients with T2D and the obese individuals should be healthy.
- Lean controls should be healthy, lean and drug naive.
- Obese and lean controls should have no first degree family history of diabetes.
- All participants should be 30-65 years old.
- All participants should be able to provide informed written consent.
Exclusion
- Any unknown disease or need for medication that occurs after inclusion.
- Abnormal ECG, screening blood tests and/or severe hypertension (\>160/100 mmHg).
- Impaired glucose tolerance (IGT) or impaired fasting glucose in lean, healthy participants (2-hour plasma glucose \> 7.8 mmol/l or fasting plasma glucose \> 5.6 mmol/l).
- Known pregnancy or positive beta-HCG in blood during screening.
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2023
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT05291013
Start Date
July 1 2022
End Date
April 30 2023
Last Update
March 22 2022
Active Locations (1)
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1
Kristoffer Jensen Kolnes
Odense, Denmark, 5000