Effect Dietary Fructose on Fructose Kinetics in Type 2 Diabetes

NCT05717608 | Recruiting

• 1 other identifier: 2022.0606 - NL82353.018.22
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Determine the kinetics of fructose metabolism and its role as a metabolic substrate following a high (100gr/day) vs low fructose diet (\<30 gram fructose intake per day isocaloric correction with dextrose) in type 2 diabetic subjects of SAS or Caucasian ethnicity.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• fructose on glucose metabolism

  to correlate changes in oral fructose handling (measured by a fructose challenge test (AUC) with 13C6-labeled fructose in relation to metabolic effects on HOMA-IR and continuous glucose monitoring (Freestyle libre MAGE) at baseline and after 4 weeks of dietary intervention.

  4 weeks

Secondary Outcomes (2)

• changes in microbiota composition

  4 weeks

• changes in (postprandial )plasma metabolites

  4 weeks

Study Arms (4)

high fructose in caucasian dutch type 2 diabetes subjects

ACTIVE COMPARATOR

high (100gr/day) fructose diet for 4 weeks in type 2 diabetic subjects of Caucasian ethnicity.

Other: high vs low fructose in caucasian dutch or surinamese asian type 2 diabetes subjects

low fructose in caucasian dutch type 2 diabetes subjects

PLACEBO COMPARATOR

low fructose diet (\<30 gram fructose intake per day isocaloric correction with dextrose) for 4 weeks in type 2 diabetic subjects of Caucasian ethnicity.

Other: high vs low fructose in caucasian dutch or surinamese asian type 2 diabetes subjects

high fructose in surinamese asian type 2 diabetes

ACTIVE COMPARATOR

high (100gr/day) fructose diet for 4 weeks in type 2 diabetic subjects of SAS ethnicity.

Other: high vs low fructose in caucasian dutch or surinamese asian type 2 diabetes subjects

low fructose in surinamese asian type 2 diabetes

PLACEBO COMPARATOR

low fructose diet (\<30 gram fructose intake per day isocaloric correction with dextrose) for 4 weeks in type 2 diabetic subjects of SAS ethnicity.

Other: high vs low fructose in caucasian dutch or surinamese asian type 2 diabetes subjects

Interventions

high vs low fructose in caucasian dutch or surinamese asian type 2 diabetes subjects OTHER

oral ingestion of food supplement for 4 weeks

high fructose in caucasian dutch type 2 diabetes subjects; high fructose in surinamese asian type 2 diabetes; low fructose in caucasian dutch type 2 diabetes subjects; low fructose in surinamese asian type 2 diabetes

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• T2D patients (20 Caucasian and 20 SAS)
• years old
• Male-female
• BMI 25-35 kg/m2
• Stable anti diabetic drugs for 3 months (metformin is obligatory)
• Stable medication use past 3 months
• Able to give informed consent

You may not qualify if:

• \- Proton-pump inhibitor usage (known to effect gut microbiota)
• GLP1, SGLT2i or insulin use (known to effect gut microbiota)
• Antibiotic for the past 3 months (known to effect gut microbiota)
• Probiotic or symbiotic usage (known to effect gut microbiota)
• Pregnant women
• Chronic illness (including a known history of heart failure, renal failure (eGFR \<30 ml/min), pulmonary disease, gastrointestinal disorders, or hematologic diseases), or other inflammatory diseases
• Active infection
• Previous intestinal (e.g., bowel resection/reconstruction) surgery
• Smoking (due to its influence on gut microbiome)
• Vegetarian diet (since they have different microbiota)
• \>6 alcohol units per day or \>14 alcohol units per week
• Active malignancy
• HbA1c \>9% (75mmol/mol)

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Amsterdam UMC location AMC

Amsterdam, Netherlands

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• max nieuwdorp

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

cengiz callender, MD

CONTACT

0031 20 5669111; c.callender@amsterdamumc.nl

max nieuwdorp, MD PhD

CONTACT

0031 20 5669111; m.nieuwdorp@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: supplementation with either fructose or dextrose
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: high versus low fructose diet for 4 weeks in either caucasian or surinamese asian type 2 diabetes patients

Study Record Dates

• First Submitted: January 8, 2023
• First Posted: February 8, 2023
• Study Start: February 5, 2023
• Primary Completion: December 31, 2025
• Study Completion: April 30, 2026
• Last Updated: February 8, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)