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The effect of diet-induced weight loss on glucose metabolism (the METALIFE study).

The metabolic impact of diet-induced weight loss in individuals with distinct tissue-specific insulin resistance - The metabolic impact of a lifestyle intervention (the METALIFE-study)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON58142
Enrollment
40
Registered
2025-03-28
Start date
2026-02-03
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity Overweight / obesity

Interventions

The 12-week energy-restricted diet will involve an relative&nbsp
caloric reduction of 25% below the estimated daily energy requirement, which is calculated by multiplying the basal metabolic rate by a physical activity level (PAL) of 1.5. Alongside this caloric res

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Aged 40-75 yearsBMI = 28 and = 40 kg/m2Being able to fit in the 7T MRI scanner: waist and hip circumferences = 125 cmStable body weight for at least 3 months prior to study participation (± < 3 kg)Classified as either predominant LIR or MIR  (LIR: HIRI > 592 and MISI > 0.116; MIR: HIRI < 509 and MISI < 0.094)

Exclusion criteria

Exclusion criteria: -    Diabetes mellitus type 1 or 2  (i.e., FPG = 7,0 mmol/L and HbA1c = 6.5% (48 mmol/mol) (29)) -    Cardiovascular diseases (e.g., heart failure) or cancer (e.g., non-invasive skin cancer is allowed)   -    Pulmonary diseases: no history of chronic obstructive pulmonary disease, emphysema, bronchitis (asthma is allowed) -    Auto-immune diseases -    Kidney (e.g. kidney failure) or liver (e.g. cirrhosis, non-alcoholic fatty acid) malfunction (pre-diagnosis or determined based on ALAT, ASAT and creatinine values) -    Major gastrointestinal diseases or major abdominal surgery (allowed i.e.: appendectomy, cholecystectomy) -    Anemia defined as Hb men <8.5 and women <7.5 mmol/l -    Food allergies, intolerances (including gluten/lactose intolerance) and/or eating disorders interfering with the study -    High blood pressure (untreated >160/100 mmHg, treated >140/90 mmHg)  -    Diseases affecting glucose and/or lipid metabolism (e.g., pheochromo-cytoma, Cushing’s syndrome, acromegaly) -    Diseases with a life expectation shorter than 5 years  -    Major mental disorders -    Drug treated thyroid diseases (well substituted hypothyroidism is allowed for inclusion)  -    Other physical/mental conditions that may interfere with study outcomes -    Medication that influences glucose or lipid metabolism or inflammation such as: o    Use of statins (stable use =3 months prior to and during study is allowed) o    Use of antidepressants (stable use =3 months prior to and during study is allowed) o    Use of anticoagulants (acetylsalicylic acid is allowed) o    Use of ß-blockers o    Use of glucose lowering medication (e.g., DPP-4 inhibitors, SGLT2 inhibitors, GLP-1 receptor agonists) o    Chronic corticosteroid treatment (> 7 consecutive days) o    Use of immunosuppressives o  Chronic use of NSAIDs -    Use of antibiotics within 3 months prior to the study-    Use of antipsychotic medication-    Abuse of alcohol (consumption >14 units/week) and/or drugs (cannabis included)-    Not willing to limit alcohol consumption to 7 units per week -   No habitual smoking (including use of e-cigarettes and vapes) -    More than 4 hours/week moderate-to-vigorous physical activity -    Having a restricted dietary pattern interfering with the study diet (e.g., vegan, Atkins diet and/or other special diets) – vegetarian diets are permitted -    Use of high-dose vitamins or other dietary supplements (e.g., pre- or probiotics) exceeding the Recommended Dietary Allowance (RDA), which are expected to interfere with the study outcomes. -    Pregnant or lactating women, or women who are planning to become pregnant  -    Inability to comply with the dietary recommendation

Design outcomes

Primary

MeasureTime frame
The primary objective of this study is to examine the difference in changes in peripheral insulin sensitivity following a 12-week dietary intervention, consisting of energy restriction and dietary guidance based on the Dutch national guidelines, between individuals with more pronounced LIR and those with more pronounced MIR. 

Secondary

MeasureTime frame
We will also perform a head-to-head comparison of DMI and the hyperinsulinemic-euglycemic clamp as research tools for the measurement of skeletal muscle glucose disposal. Additionally, we aim to study the effects of a 12-week energy-restricted diet on changes in: Anthropometrics (weight, height, waist and hip circumferences)Body composition and body fat distributionLipid content and composition in liver, skeletal muscle and adipose tissue Energy and substrate metabolism (energy intake, energy expenditure, fat and carbohydrate oxidation) Whole-body and tissue-specific insulin sensitivityBeta cell functionFasting plasma glucose, insulin, HbA1c, blood lipid profiles, and inflammatory markersMitochondrial respiration and gene/protein expression in adipose tissue and skeletal muscle Composition of microbiomeBlood pressureQuality of life and gastrointestinal health 

Countries

Netherlands

Contacts

Public ContactGH Goossens

Universiteit Maastricht

g.goossens@maastrichtuniversity.nl+31 (0)43 3881314

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 11, 2026