Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2022-06-28
2023-03-01
Brief Summary
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Detailed Description
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* A modified two-stage Insulin Suppression Test to determine insulin mediated glucose uptake. Fasting participants receive body-surface-area-adjusted octreotide, insulin and glucose infusions for 240 minutes. Octreotide is infused with the same rate throughout the test. Insulin and glucose infusions are slow for the initial 120-minute stage and increased the final 120-minute stage, simulating fasting and post-postprandial conditions, respectively. Steady state measurements of plasma glucose are acquired the final 30 minutes of each stage, at time points 100, 110, 120, 220, 230 and 240 minutes.
* A mixed meal test. Fasting participants consume 75 g. white bread, 10 g. butter, 30 g. cheese and 200 ml. orange juice. Blood samples are drawn at time points -15, 0, 15, 30, 60, 90, 120, 180 and 240 min for glucose-, insulin-, glucagon- and triglyceride measurements.
* A Magnetic Resonance Imaging (MRI) scan. Participants undergo dixon-sequences scanning the abdomen, assessing visceral and sub-cutaneous fat volume and liver fat content. Magnetic Resonance (MR) spectroscopy is also used to determine fat percentage of the liver.
* 24-hour ambulatory blood pressure measurement, every 20 minutes during daytime and every 30 minutes during nighttime.
* 1-week continuous glucose measurement using blinded continuous glucose monitor/sensor on upper arm.
* Fecal and urine sampling
* 72-hour food-diary
* Fasting blood samples:
* Insulin, c-peptide, HbA1c and glucose
* Total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL) and triglycerides
* Thyroid-stimulating hormone (TSH)
* Alanine aminotransferase, creatinine, sodium and potassium
* High sensitivity C reactive protein (CRP) and alpha-hydroxybutyrate
* C-terminal telopeptide (CTX) and Procollagen type 1 N-terminal propeptide (P1NP)
* Parathyroid hormone (PTH), Vitamin D and Ionized calcium
* Monocyte Chemoattractant Protein-1 (MCP-1)
* Interleukin 1 \& 8 (IL-1α, IL-1β, IL-8)
* Gastric inhibitory polypeptide (GIP), Glucagon-like peptide-1 (GLP-1) and Glucagon- like peptide-2 (GLP-2)
* Growth/differentiation factor 15 (GDF-15)
* Tumor necrosis factor (TNFα)
* Fasting assessment of insulin resistance (Homeostatic Model Assessment for Insulin Resistance by C-peptide).
Pre-intervention and end-intervention test results will be compared using repeated-measures ANOVA / mixed models.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Cafestol
Participants in this arm ingest 6 mg cafestol capsules twice daily with breakfast and dinner.
Cafestol
Capsule with 6 mg cafestol twice daily
Placebo
Participants in this arm ingest placebo capsules twice daily with breakfast and dinner.
Placebo
Capsule without cafestol twice daily
Interventions
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Placebo
Capsule without cafestol twice daily
Cafestol
Capsule with 6 mg cafestol twice daily
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Pregnancy
* Planned pregnancy
* Breastfeeding
* Significant comorbidity expected to unable the subject from completing visits
18 Years
80 Years
ALL
Yes
Sponsors
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Aarhus University Hospital
OTHER
University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Søren Gregersen, M.D. Ph.D
Role: PRINCIPAL_INVESTIGATOR
Aarhus University Hospital
Locations
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Steno Diabetes Center Aarhus
Aarhus, Aarhus N, Denmark
Countries
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Other Identifiers
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cafestol.longterm
Identifier Type: -
Identifier Source: org_study_id
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