CompletedNot ApplicableInterventional

Impact of exercise training in combination with dapagliflozin on physical function in adults with type 2 diabetes mellitus

Type 2 diabetes can cause muscles to lose strength faster as we age. This can make everyday activities, like climbing stairs or carrying shopping, feel much harder. While losing weight can improve blood sugar, it can also lead to muscle loss if people are not active. This clinical study in Leicester is testing whether a common diabetes medicine called dapagliflozin works better alongside exercise to improve strength and stamina. Dapagliflozin lowers blood sugar by removing excess sugar through urine, which also helps with weight loss. Participants aged 40 to 75 will be split into three groups for 24 weeks: one taking dapagliflozin alone, one taking the medicine with supervised exercise sessions, and one following a structured diet plan. Researchers will check muscle strength, heart health, and blood sugar to find out which approach best supports long-term independence.

At a glance

Status

Completed

Phase

Not Applicable

Sponsor

University of Leicester

Enrolment target

135

Start

20 May 2021

Estimated completion

13 Jan 2025

Diabetes mellitus

What is this study about?

Type 2 diabetes affects the body in many ways, including how our muscles age. Over time, people living with diabetes may notice that their muscles lose strength and stamina more quickly. This can lead to a condition known as impaired physical function or frailty, making ordinary daily tasks feel exhausting. Because many adults with type 2 diabetes also carry extra weight, moving around can become even more challenging.

Doctors often recommend losing weight through diet to help manage blood sugar. However, dieting alone can cause people to lose muscle alongside fat, which may actually reduce their physical strength. Regular exercise helps keep muscles strong, but staying active can be difficult without the right guidance and support. Researchers want to find treatments that help people manage their weight and blood sugar while protecting their muscle strength.

This trial investigates a diabetes medicine called dapagliflozin (also known as Forxiga). Dapagliflozin is already widely prescribed in the UK. It works by helping the kidneys pass extra sugar out of the body through urine, which can lead to healthy weight loss. The research team wants to see if combining dapagliflozin with a structured exercise programme gives a bigger boost to physical fitness than the tablet alone or a healthy eating plan. The results could help doctors provide better lifestyle and treatment plans to keep people with diabetes active and independent.

Key takeaways

Tests whether combining dapagliflozin with exercise improves everyday fitness in type 2 diabetes.
Open to adults aged 40 to 75 who are overweight and noticing some loss of physical fitness.
Participants are randomly assigned to take medicine alone, medicine with exercise, or follow a diet plan.
The study lasts 24 weeks and is based at hospitals in Leicester.
Provides regular health check-ups, detailed heart scans, and expert lifestyle guidance.

Who may be eligible?

This study is designed for adults aged 40 to 75 who have type 2 diabetes. To take part, your diabetes should currently be managed either through lifestyle changes alone or with standard diabetes tablets. Your weight and diabetes medication should have been generally stable over the last three months.

Participants should have a body mass index (BMI) of 25 or higher, or 22.5 or higher for people from a South Asian background. You should also have had a recent long-term blood sugar check (HbA1c) that shows your diabetes is within a specific range (up to 10.5% or 91 mmol/mol).

Because the study focuses on physical strength, participants should be experiencing some mild loss of fitness or muscle strength, but still be physically able and safe to take part in light-to-moderate exercise. You must also be able to travel to hospital sites in Leicester for appointments.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 40 and 75 years old?
Have you been diagnosed with type 2 diabetes?
Is your BMI 25 or over (or 22.5 or over if you are of South Asian background)?
Has your weight and diabetes treatment remained steady over the last 3 months?
Have you noticed that everyday physical tasks feel more tiring or difficult?
Are you able to travel to Leicester for clinic visits and supervised sessions?

Answer every question to see your result.

What does participation involve?

Taking part in the study lasts for 24 weeks (about six months) and involves five main hospital visits. Before the study begins, you will attend a screening check where a doctor reviews your medical history, checks your heart rhythm with an ECG, and runs routine blood and urine tests. Visits take place at Leicester General Hospital and Glenfield Hospital, and include heart scans (MRI and ultrasound), body fat scans, and simple physical fitness tests. You will also wear a small waterproof activity tracker on your wrist for a week at a time and complete food and activity diaries.

After your baseline tests, you will be randomly placed by computer into one of three groups. Group A takes a daily dapagliflozin tablet. Group B takes the daily tablet and joins a 24-week tailored exercise programme, starting with supervised gym sessions in Leicester before moving towards home workouts. Group C follows an individual healthy eating plan created by a specialist dietitian. The team will stay in close contact throughout the study, including regular phone calls at weeks 2, 4, 8, and 18 to see how you are feeling.

Potential risks and benefits

You may benefit from close medical supervision of your diabetes, detailed health scans, and expert advice on diet or exercise. Depending on your group, you may see improvements in your fitness, blood sugar control, and weight. However, there are potential side effects. Dapagliflozin can cause dehydration, thrush, or urinary tract infections, and more rarely, very low blood sugar or serious metabolic complications. The tests involve minor inconveniences, such as slight bruising from blood tests, tightly fitting exercise masks, and lying still during scans. Taking part is completely voluntary. You are free to withdraw from the study at any time, and doing so will not affect your normal NHS care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University Hospitals Of Leicester NHS Trust
City only
Leicester, England

Common questions

What is dapagliflozin?

Dapagliflozin is a standard prescription tablet approved in the UK for type 2 diabetes. It works by helping your kidneys remove excess sugar from your bloodstream through your urine.

Can I choose whether I get the exercise, medicine, or diet plan?

No. A computer places participants into groups at random, like flipping a coin. This ensures the study results are fair and scientifically accurate.

Do I have to pay for the study visits or exercise sessions?

No, all study-related treatments, supervised gym sessions, tests, and dietary consultations are provided free of charge during the trial.

What happens if I experience side effects during the study?

A doctor monitors your health throughout the study. You will have regular review phone calls and can contact the research team at any time for advice. If needed, the medication can be stopped.

Will I keep taking the study medicine after the 24 weeks finish?

At your final visit, the study doctor will discuss whether the medication worked well for you. If appropriate, they can write to your regular GP to recommend reviewing your ongoing diabetes treatment.

How to find out more

Emily James

emily.james45@nhs.net +44 (0)116 258 8922 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.