ClinicalTrials.gg
Active, not recruitingNCT06745362WeR-LIM-SMBAUpdated Aug 10, 2026

Weight Reduction With the Low-Insulin-Method - Self Monitoring of Breath Acetone

An interventional study of self-monitoring of breath acetone and lifestyle-intervention via LIM-App in Overweight and Obese Volunteers, sponsored by West German Center of Diabetes and Health. Active, not recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-10.

Sponsored by West German Center of Diabetes and Health · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 149 studies in Overweight with a site in Germany — 38 open to participants now, 60 under way, 34 of them phase 3. Overweight · Germany.

Planned enrollment
120th of 141
42 · median 137
Started
2025
with 24 others
No phase
52 of 149
10 open now
Primary completion
2027-12
later than 29 of 59 live
Registered
91st of 149
by date
Lead sponsor
7 of 149
West German Center of Diabetes and Health

Among the 149 studies in Overweight with a site in Germany, this one is the 120th largest by planned enrollment of the 141 interventional ones that give a count, is one of 25 that started in 2025, is one of 52 with no phase, reaches primary completion later than 29 of the 59 other live ones, and was the 91st registered.

Overweight

3,599 studies on the registry are indexed under Overweight; 852 are open to participants now.

Browse Overweight studies →

Open to participants now

38 of the 149 studies in Overweight with a site in Germany are open now. Recruiting first, the newest first:

33 more — sign in →

All 38 open studies →

A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →

Who these studies take

Of the 529 Overweight studies recruiting now, 158 (30%) set no upper age limit and 343 (65%) stop at 75 or younger; 62 take children under 18; 204 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 149 studies in Overweight with a site in Germany, or all of them as a file.
02

Study summary

The goal of this clinical trial is to learn if lifestyle intervention with information about ketosis state supports weight reduction in overweight adults.

Researchers will compare an App-based lifestyle intervention with self-monitoring of breath acetone vs. lifestyle intervention alone.

Participants will:

Get a lifestyle intervention via the LIM-App for 12 months. Report body weight.

Read the detailed description

Background: Overweight and obesity are an increasing problem. Therefore, the Low-Insulin-Method was developed to support overweight and obese people in weight loss.

Method: In a randomized controlled clinical trial, the effect of the lifestyle intervention program 'Low-Insulin-Method', delivered by the Low-Insulin-App including low-carb diet, physical activity, self monitoring of weight, and self-monitoring of breath acetone (SMBA) is examined compared to a control group without information about ketosis level. Weight change will be compared after 3 and 12 months.

Objective: The aim is to develop a training and counseling program for overweight or obese individuals with diabetes risk or type 2 diabetes, which can be used both for primary and for tertiary prevention of overweight-related diseases.

03

Conditions studied

  • Overweight and Obese Volunteers

Keywords

  • lifestyle intervention
  • weight reduction
  • ketosis
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • > 25kg/m2

Exclusion criteria

Exclusion Criteria:

-

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
42 participants (estimated)

Study arms

  • Experimental
    Intervention group

    lifestyle intervention including information about ketosis level

    Other: self-monitoring of breath acetone · Other: lifestyle-intervention via LIM-App

  • Active comparator
    control group

    lifestyle intervention without information about ketosis level

    Other: lifestyle-intervention via LIM-App

Interventions

  • Otherself-monitoring of breath acetone

    Participants perform self-monitoring of braeth acetone in order to get information about their ketosis state.

  • Otherlifestyle-intervention via LIM-App

    Participants are offered a lifestyle intervention via LIM-App.

06

What researchers measure

Primary outcomes

  1. body weight

    body weight in kg

    Time frame: 3 months

Secondary outcomes

  1. body weight

    body weight in kg

    Time frame: 12 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No — upon request

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2025 (actual). Primary completion is estimated for Dec 2027, 35 months after the start.

Of 1,300 non-industry interventional studies with no phase under Overweight, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 38. This study's planned 35 months is above that.

Counting every sponsor, half of 1,411 studies reached it within 17 months; a quarter within 8 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 17, 2024
First posted
Dec 20, 2024
StartActual
Jan 1, 2025
Primary completionEst.
Dec 31, 2027
CompletionEst.
Dec 31, 2027
Last update
Aug 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06745362
Lead sponsor
West German Center of Diabetes and Health
Responsible party
Sponsor
First posted
Dec 20, 2024
Start date
Jan 1, 2025
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Aug 10, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion