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Obesity and OverweightNCT07026903

The Impact of CGM on Weight Reduction

A study testing resistance exercise and calorie restrictive diet in people with Obesity and Overweight and the Study Will Focus on Weight Reduction Through Lifestyle Changes Aided by Insights From Continuous Glucose Monitoring, run by University of Zagreb at 1 site in Croatia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this randomized control study is to learn if continuous glucose monitoring (CGM) can aid in weight loss in overweight/obese women with no other chronic condition. The primary hypothesis is that insights from CGM aid in greater weight loss, and the secondary hypothesis is that the use of CGM reduces the… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
resistance exercise and calorie restrictive diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteCroatia
Study dates
1 Nov 2024to 2 May 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Inclusion Criteria: females, age over 18 years, overweight/obese

Exclusion Criteria: prediabetes/diabetes, significant anemia, clinically manifest hypo- or hyperthyroidism, recent musculoskeletal injuries that would limit participation in the exercise

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Trial locations and contacts

1 site in 1 country.

Croatia1 site
  • Fitness centre "Fit by Ines"

    Čakovec, 40000

Other trials in Croatia

About this study

Official title: The Impact of CGM on Weight Reduction in Women With Overweight/Obesity Without Accompanying Chronic Diseases

The goal of this randomized control study is to learn if continuous glucose monitoring (CGM) can aid in weight loss in overweight/obese women with no other chronic condition. The primary hypothesis is that insights from CGM aid in greater weight loss, and the secondary hypothesis is that the use of CGM reduces the dropout rate from a three-month exercise program. Research will compare the results of weight loss after inclusion into 3 month physical exercise and diet counselling program between experimental group (women assigned to wear CGM) and control group (women without CGM). All participants will be included in the same physical exercise program with a fitness coach (3 times weekly for 60 minutes per sessions, three different resistance trainings), and will be given a calorie-controlled diet based on a weekly menu.

Read the detailed description

In this prospective study lasting 3 months, a total of 40 participants are planned to be included. The sample size was calculated using the free G Power program. For differences within the group (before-after measurements, 2 measurements), the required number of participants in one group would be 16 (with a power of 0.8 and the calculated effect size based on previous research = 0.66). Considering that differences between two groups will also be observed, the calculation was made more conservatively, using a moderate effect size factor for ANOVA for repeated measures (within-between interaction), and with a minimum required power of 0.8 and an effect size of 0.25, the total number of required participants is 28, which means 14 per group, assuming three BMI measurements. Due to the potential dropout rate, the sample size was increased to 20 participants per group. Participants will be recruited upon enrollment at the fitness center. Participants will be randomly divided into two groups; one that will use isCGM (FreeStyle Libre 2) for glucose control and nutritional choices, and a group without CGM (the control group). At the beginning of the study, all participants will have their body composition measured on a scale, BMI, waist and hip circumference, triceps skinfold thickness, and blood samples taken for biochemical analyses (CBC, glucose, HbA1c, lipid profile, aminotransferases, fT4, and TSH). Blood tests will be analyzed in the private laboratory. Only those participants who do not have glucose metabolism disorders (prediabetes or diabetes), significant anemia, clinically manifest hypo- or hyperthyroidism, or recent musculoskeletal injuries that would limit their participation in the exercise program will be included in the further study. All participants will undergo nutritional counseling and receive a proposal for a calorie-controlled diet based on a weekly menu. Participants will be asked to keep a food diary. Additionally, all participants will follow the same exercise program for 3 months under the professional guidance of a kinesiologist. Exercise will be conducted 3 times a week for 60 minutes in groups of up to 5 participants, and will include three different training sessions with external and bodyweight resistance. In the case of external resistance, weights will be adjusted according to the participants' status so that they can complete the assigned number of repetitions, and in the case of bodyweight exercises, participants who cannot complete the prescribed series will be allowed to take breaks between repetitions. At the midpoint of the program, after 1.5 months of research, body composition will be re-evaluated on the scale, and measurements of the triceps skinfold and waist and hip circumference will be repeated. Participants assigned to the CGM group will wear sensors (FreeStyle Libre 2, Abbott) for 2 weeks three times during the study (at the beginning, after 1.5 months, and after 3 months). At the end of the program, anthropometric measurements and biochemical indicators will be repeated as at the beginning of the study. Data will only be analyzed for those participants who attend more than 90% of the exercise sessions. Dropout rates and participant satisfaction with the program will be monitored, knowledge of macronutrients will be compared before and after the program, and initial and control laboratory results and anthropometric measures will be compared.

Being tested
resistance exercise and calorie restrictive diet
Medical subject headings
Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • resistance exercise and calorie restrictive dietBehavioural

    experimental group will be randomized to isCGM during the lifestyle intervention trial while control group will participate in the same lifestyle intervention but will not use isCGM

Study groups in NCT07026903
Study groupRoleWhat they receive
experimental-randomized to isCGMOtherexperimental arm- participants randomized to isCGM during the 3 months lifestyle intervention trial duration control arm-participants not randomized to isCGM during the 3 months lifestyle intervention trial duration
Receives: Behavioral: resistance exercise and calorie restrictive diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change from baseline in the body mass index and body composition

    we will measure, compare and report changes in body weight, BMI and body composition in women living with overweight/obesity allocated to lifestyle measures+CGM and lifestyle measures without CGM

    Measured: the study will last for 3 months

Secondary outcomes (1)
  1. changes in drop out rate between women living with overweight/obesity allocated to lifestyle intervention+CGM and those on lifestyle intervention

    we hypothesize that addition of CGM to lifestyle intervention will improve the adherence rate

    Measured: the study will last for 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2025
  2. Study start1 Nov 2024
  3. Primary completion2 May 2025
  4. Study completion2 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Model description
women living with overweight/obesity will be allocated to either a group with or without addition of continuous glucose monitoring (CGM) in addition to lifestyle intervention
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07026903
Sponsor's protocol ID
84
Status last verified
Jun 2025
First submitted
10 Jun 2025
Last updated
18 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing resistance exercise and calorie restrictive diet in people with Obesity and Overweight and the Study Will Focus on Weight Reduction Through Lifestyle Changes Aided by Insights From Continuous Glucose Monitoring, run by University of Zagreb at 1 site in Croatia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change from baseline in the body mass index and body composition (time frame: the study will last for 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.

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