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New treatment option for Type 2 Diabetes
Official title A Feasibility Study of Optimal Non-Pharmacological Lifestyle Modifications in People With Type 2 Diabetes
ClinicalTrials.gov ID: NCT07262788
What this study is testing
- What it's testing
- The overall aim of this study is to examine the feasibility of a 12-month, two-arm lifestyle intervention to induce and maintain remission of type 2 diabetes (T2D). The findings from the feasibility study will inform the recruitment, design and delivery of the interventions in a 5-arm, 24-month randomised controlled trial.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Building on previous findings from T2D remission studies involving VLCD interventions, the study include individuals with recently diagnosed T2D who...
- Diagnosis of T2D. Treatment lifestyle changes, oral anti-diabetic medication including metformin, and/or sulfonylureas and/or DPP-4 inhibitors and/or...
- HbA1c between 36-86 mmol/mol
- T2D duration of ≤6 years
- BMI ≥27 kg/m2
You likely can't join if
- Insulin treatment within 6 months prior to screening (any type)
- Heart failure (ejection fraction ≤40%) and treated with SGLT-2i (current or planned)
- Cardiovascular disease, including previous heart attack or stroke, for which incretin-based therapy and/or an SGLT-2i has been prescribed.
- Kidney disease (eGFR \<60 ml/min/1,73m² and/or albuminuria (≥30 mg/g) for at least three months) and treated with SGLT-2i (current or planned)
- Physical comorbidity, which precludes the physical activity during intervention
- Dietary restrictions or allergies making the participant unable to adhere to the dietary interventions
See the full eligibility criteria
- Building on previous findings from T2D remission studies involving VLCD interventions, the study include individuals with recently diagnosed T2D who are overweight or obese and not receiving insulin therapy. This...
- Diagnosis of T2D. Treatment lifestyle changes, oral anti-diabetic medication including metformin, and/or sulfonylureas and/or DPP-4 inhibitors and/or SGLT2 inhibitors and/or incretin-based medication
- HbA1c between 36-86 mmol/mol
- T2D duration of ≤6 years
- BMI ≥27 kg/m2
- Body weight changes over 3 months ≤3 kg
- Insulin treatment within 6 months prior to screening (any type)
- Heart failure (ejection fraction ≤40%) and treated with SGLT-2i (current or planned)
- Cardiovascular disease, including previous heart attack or stroke, for which incretin-based therapy and/or an SGLT-2i has been prescribed.
- Kidney disease (eGFR \<60 ml/min/1,73m² and/or albuminuria (≥30 mg/g) for at least three months) and treated with SGLT-2i (current or planned)
- Physical comorbidity, which precludes the physical activity during intervention
- Dietary restrictions or allergies making the participant unable to adhere to the dietary interventions
- Unable to comply with trial procedures and/or interventions
- Alcohol/drug abuse
- Planned or present pregnancy/fertility treatment, or lack of contraception during reproductive age
- Unstable psychiatric disease that is deemed to impede participation in the project
- Diagnosed with binge eating disorder
- Participation (present or planned) in other clinical trials including lifestyle or pharmacy trials for any condition
- If HbA1c ≥60 mmol/mol and the participant is on 2 or more anti-diabetic drugs and has a positive GAD65 and/or stimulated C-peptide \<800 pM
The study team makes the final eligibility decision.
Where it's taking place
- Herlev, Denmark, Denmark
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, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Herlev, Denmark, Denmark. 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.