Effects of a 6 months low-carb dietary intervention on glycemic control, body composition and gut-brain interaction in obese and lean patients with and without glucose intolerance or diabetes
Eligibility
Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Effect of a low-carb dietary intervention on glycemic control as defined by blood glucose level at 2h after an oral glucose tolerance test. — Change from baseline to 6 months
Trial sites (1)
Facility
City
Region
Status
St Clara Research Ltd, St Claraspital Basel
Basel
Switzerland
More University Hospital, Basel, Switzerland trials in Switzerland
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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