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Effects of fructose on glucose and lactate excursions during an oral glucose tolerance test

Effects of fructose on glucose and lactate excursions during an oral glucose tolerance test - Effects of fructose added to OGTT

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON49169
Enrollment
74
Registered
2019-04-17
Start date
2019-05-09
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

Sugar tolerance

Interventions

For substudy I, all participants will undergo eight OGTTs in total, including one standard OGTT, five standard OGTTs with addition of different dosages of fructose, one standard OGTT with addition o

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Substudy I: Healthy men, age 18-75 years, blood Hb >= 8,2 mmol/L. Healthy women, age 18-75 years, blood Hb >= 7,3 mmol/L, either postmenopausal women or premenopausal using an oral contraceptive without a *stop week*, Substudy I protocol amendment for the 10 additional study participants: Healthy men, age 18-75 years. Healthy women, age 18-75 years, either postmenopausal women or premenopausal using an oral contraceptive without a *stop week*, Substudy II: a) Genetic diagnosis (i.e. heterozygous carrier) of aldolase B mutation, age 18-75 years. b) Genetic diagnosis of Maturity-Onset Diabetes of the Young Type 2 (MODY-2), i.e. carrier of glucokinase mutation, age 18-75 years. c) Healthy individuals, age 18-75 years.

Exclusion criteria

Exclusion criteria: • Fasting blood glucose >11 mmol/L; • Clinical diagnosis of diabetes including type 1 and type 2; • Use of medications known to interfere with glucose homeostasis (i.e. corticosteroids); • Medical conditions that can interfere with the study outcome (i.e. gastrointestinal disease); • Cancer, end-stage liver, kidney, cardiac or lung disease; • Unstable weight for 3 months prior to inclusion (i.e. 5% change in bodyweight (13)); • Abuse of drugs and/or alcohol; • Pregnancy; • Physical stress one month prior to inclusion (i.e. post-surgery, trauma or infection or extreme psychological stress); • Periodic hypokalemic paralysis; • Inability to give inform consent.

Design outcomes

Primary

MeasureTime frame
The area under the curve (AUC) for plasma glucose and lactate excursions during an OGTT will be calculated. The glucose and lactate AUC*s for the OGTT without fructose will be compared to the glucose and lactate AUC*s for the OGTT(s) with fructose.

Secondary

MeasureTime frame
Secondary parameters: Serum fructose, insulin, triglycerides, urate and beta-hydroxybutyrate levels will be measured at baseline and the end of each OGTT and compared with the OGTT without fructose. Urinary fructose will be measured at the end of each OGTT and compared with the OGTT without fructose. Furthermore, plasma will be stored future analyses. Other study parameters include: • Age • Sex • BMI • Waist and hip circumference • Fasting plasma glucose • Fasting serum insulin • Fasting serum lipids (total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides) • Systolic and diastolic blood pressure

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)