Adipose Tissue Dysfunction in Type 2 Diabetes and Its Reversibility by Bariatric Surgery (ADIDYS)

  • STATUS
    Recruiting
  • End date
    Apr 30, 2023
  • participants needed
    45
  • sponsor
    Odense University Hospital
Updated on 11 April 2022

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 lipid deposition plays an important role in obesity-induced IR, but its role in T2D pathogenesis and to what extent insulin-sensitizing interventions can reverse AT dysfunction remain to be clarified.

Hypothesis/aims: To test the hypotheses 1) that T2D is associated with exaggerated AT dysfunction compared with obesity alone, 2) that increased insulin sensitivity and remission of T2D after bariatric surgery is in part explained by improved AT function Research plan: Novel markers of exaggerated AT dysfunction will be identified and studied together with known markers of AT dysfunction in patients with T2D compared with non-diabetic obese and lean individuals. Then the effects of bariatric surgery on all these markers of AT dysfunction in obesity and T2D will be studied. Adipose tissue and skeletal muscle biopsies and blood samples will be used for 1) next generation RNA sequencing, 2) targeted analysis of mRNA and protein content/activities, 3) metabolomics, 4) morphological analysis and 5) analysis of adipokines/myokines. Abnormalities in T2D and changes in response to bariatric surgery will be related to substrate metabolism, insulin sensitivity and secretion and insulin signalling in muscle.

Perspectives: This project provides novel insight into the role of AT dysfunction in T2D pathogenesis in humans and the potential of bariatric surgery to reverse AT dysfunction and improve insulin sensitivity. We ultimately expect that this will help us to identify novel pharmaceutical targets for the treatment of IR.

Details
Condition Adipose Tissue Dysfunction Type 2 Diabetes Mellitus Bariatric Surgery
Treatment Gastric byspass
Clinical Study IdentifierNCT05291013
SponsorOdense University Hospital
Last Modified on11 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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