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New treatment option for Type 2 Diabetes
Official title Improving Insulin Sensitivity in Patients With Type 2 Diabetes Via Repeated Cold-induced Shivering Thermogenesis
ClinicalTrials.gov ID: NCT07573917
What this study is testing
- What it's testing
- Type 2 Diabetes Mellitus (T2DM) is a widespread health condition characterized by impaired ability of the body to maintain glucose homeostasis. This impairment often leads to secondary complications, including heart disease, high blood pressure, and poor quality of life.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 75
You may be able to join if
- Patients are able to provide signed and dated written informed consent prior to any study specific procedures
- Women are post-menopausal (defined as at least 1 year post cessation of menses)
- Aged ≥ 40 years and ≤ 75 years
- Patients should have suitable veins for cannulation or repeated venipuncture
- Body mass index (BMI) 25-38 kg/m2
You likely can't join if
- Previous enrolment in a clinical study with an investigational product during the last 3 months or as judged by the Investigator
- Participate in sports of physical activity at a moderate- to high-intensity more than 3 times a week, or as judged by the investigator
- Being cold-acclimated, e.g. having taken daily extended cold baths, working in a refrigerated environment, or practicing regular cold-water swimming/...
- Unstable body weight (weight gain or loss \> 5 kg in the last three months)
- Alcohol consumption of \>2 servings per day for man and \>1 servings per day for women
- Smoking
See the full eligibility criteria
- Patients are able to provide signed and dated written informed consent prior to any study specific procedures
- Women are post-menopausal (defined as at least 1 year post cessation of menses)
- Aged ≥ 40 years and ≤ 75 years
- Patients should have suitable veins for cannulation or repeated venipuncture
- Body mass index (BMI) 25-38 kg/m2
- Stable dietary habits (no weight loss or gain \>5kg in the past 3 months)
- Diagnosed with T2D at least 1.5 years before the start of the study
- Relatively well-controlled T2D: HbA1c \< 8.5%
- Oral glucose-lowering medication: metformin alone or in combination with sulfonylurea agents and/or on stable dose of a DPPIV inhibitor treatment for at least the last 3 months. In case of GLP-1 agonist medication...
- No signs of active diabetes-related co-morbidities like active cardiovascular diseases, active diabetic foot, polyneuropathy or retinopathy
- No signs of active liver or kidney malfunction
- Previous enrolment in a clinical study with an investigational product during the last 3 months or as judged by the Investigator
- Participate in sports of physical activity at a moderate- to high-intensity more than 3 times a week, or as judged by the investigator
- Being cold-acclimated, e.g. having taken daily extended cold baths, working in a refrigerated environment, or practicing regular cold-water swimming/ showering within 1 month of starting the study
- Unstable body weight (weight gain or loss \> 5 kg in the last three months)
- Alcohol consumption of \>2 servings per day for man and \>1 servings per day for women
- Smoking
- Being insulin-dependent and/or using SGLT2 inhibitor medications
- Patients with congestive heart failure and and/or severe renal and or liver insufficiency
- Men: Hb \<8.4 mmol/L, Women: Hb \<7.8 mmol/l
- A medical doctor will judge participation eligibility based on the medical history questionnaire, medication use and fasting blood parameters. If the medical doctor advises that a patient cannot participate, the patient...
- Being pregnant
- Having participated in another study involving PET/CT scanning in the past 1 year
The study team makes the final eligibility decision.
Where it's taking place
- Sherbrooke, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sherbrooke, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.