Adipose Tissue Heterogeneity and Its Link to Type 2 Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-08

Study Completion Date

2032-12-31

Brief Summary

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People with newly diagnosed type 2 diabetes treated with metformin that have not reached their HbA1c target (42-64 mmol/mol) will be recruited to the study. If they fulfill the inclusion and none of the exclusion criteria, they will be, after signing informed consent, randomized to a six-month intervention with either pioglitazone, empagliflozin or semaglutide. Fat biopsies are obtained from the subcutaneous abdominal area before and after a hyperinsulinemic-euglycemic clamp at baseline and after six months. Participants are regularly followed during this the intervention. The overall goal is to determine how antidiabetic-drugs affect white adipose tissue cellularity and whether adipose heterogeneity impacts on drug response. The primary outcome measure is the change in fat tissue lipolysis (glycerol release in isolated fat cells after hormone stimulation) before and after treatment.

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Detailed Description

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A detailed description of the protocol has been approved by the Swedish Medical Products Agency and the study is registered as EudraCT: 2021-002367-21.

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants are recruited to either of three groups where they receive (in addition to metformin) any of the three study drugs.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pioglitazone

Pioglitazone is known to affect fat cells and is used as an active comparator. It reduces HbA1c but increase fat mass slightly. We hypothesize that pioglitazone may have particular benefits in individuals with a specific adipose cellularity.

Group Type ACTIVE_COMPARATOR

Pioglitazone 45 mg

Intervention Type DRUG

Starts with 45 mg

Empagliflozin

Empagliflozin reduces HbA1c and increase lipolysis possibly due to increased glucagon secretion. It also reduces fat mass weight to a minor degree.

Group Type EXPERIMENTAL

Empagliflozin 25 MG

Intervention Type DRUG

Starts with 25 mg

Semaglutide

Semaglutide reduces body weight, including fat mass, to a more significant degree than empagliflozin but has no known direct effects on adipose tissue.

Group Type EXPERIMENTAL

Semaglutide 7 MG

Intervention Type DRUG

Starts with 3 mg daily for the first 2 weeks

Interventions

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Pioglitazone 45 mg

Starts with 45 mg

Intervention Type DRUG

Empagliflozin 25 MG

Starts with 25 mg

Intervention Type DRUG

Semaglutide 7 MG

Starts with 3 mg daily for the first 2 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Signed informed consent
* BMI 25 kg/m2 or higher
* HbA1c 42 mmol/mol or higher
* For fertile women, effective contraception

Exclusion Criteria

* HbA1c 65 mmol/mol or higher
* Established cardiovascular disease and/or heart failure
* Severe psychiatric condition
* Active alcoholism
* Insulin treatment
* Anticoagulant therapy (vitamin K antagonists or equivalent)
* Pregnancy, lactation
* Positive GAD or IA2 antibodies
* Low C-peptide/glucose ratio (less than 2 measured as pmol/mg per dL)
* NT-proBNP above the upper normal reference value
* Kidney disease
* Liver disease or hepatic values over twice the upper reference value
* Severe concomitant disease including ongoing cancer

Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No