Low-Carb diet shows promise for blood sugar control in obesity
NCT ID NCT04234373
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This pilot study explores how a 6-month low-carbohydrate diet affects blood sugar control, body composition, and gut-brain interactions in 40 obese adults with or without glucose intolerance or diabetes. Participants follow a low-carb eating plan, and researchers measure changes in blood sugar, body fat, and metabolites. The goal is to see if this diet can help manage blood sugar and weight in this population.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2020
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Group A: HEALTHY LEAN CONTROLS * Healthy normal weight subjects with a body-mass index of 19.0-24.9kg/m2, HbA1C \<5.7% and fasting glucose \<5.6 mmol/l * Normal eating habits * Stable body weight for at least three months * Informed Consent as documented by signature Group B: PRE-DIABETIC or DIABETIC OBESE * Pre-diabetic/Diabetic obese with a HbA1C \>5.7% and/or fasting glucose \>5.6 mmol/l) and body-mass index \> 30kg/m2, otherwise healthy * Normal eating habits * Stable body weight for at least three months * Informed Consent as documented by signature Exclusion Criteria: Group A: HEALTHY LEAN CONTROLS * Pre-existing low carb diet (less than 45% of daily energy intake by carbohydrates) * Pre-existing diet (vegetarian, vegan, gluten-free etc.) * Psychiatric illness * Alcohol abuse, (smoking allowed) * Regular intake of medications, (oral contraceptives allowed) * Intake of antibiotics within the last 3 months before inclusion * Regular intake of pro- or prebiotics * Chronic diseases of the gastrointestinal tract, history of gastrointestinal surgery with major changes to the gastrointestinal tract (e.g. bariatric surgery) * Clinically relevant acute or chronic inflammatory disease * Pregnancy * Participation in another study with investigational drug within the 30 days preceding and during the present study. Group B: PRE-DIABETIC or DIABETIC OBESE * Pre-existing low carb diet (less than 45% of daily energy intake by carbohydrates) * Pre-existing diet (vegetarian, vegan, gluten-free etc.) * Psychiatric illness * Alcohol abuse, (smoking allowed) * Regular intake of medications (except: oral contraceptives, metformin, SGLT-2, statins, and antihypertensive, which are allowed) * Intake of antibiotics within the last 3 months before inclusion * Regular intake of pro- or prebiotics * Chronic diseases of the gastrointestinal tract, history of gastrointestinal surgery with major changes to the gastrointestinal tract (e.g. bariatric surgery) * Clinically relevant acute or chronic inflammatory disease * Pregnancy * Participation in another study with investigational drug within the 30 days preceding and during the present study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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St Clara Research Ltd, St Claraspital Basel
Basel, 4002, Switzerland
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