GIP Effects at Insulin Induced Hypoglycemia in Patients With Type 2 Diabetes
GIP-HYPO-T2DM
Effects of Glucose-dependent Insulinotropic Polypeptide at Insulin Induced Hypoglycemia in Patients With Type 2 Diabetes
1 other identifier
interventional
12
1 country
1
Brief Summary
Investigation of GIP effects at fasting and hypoglycemia
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for early_phase_1 type-2-diabetes-mellitus
Started May 2011
Shorter than P25 for early_phase_1 type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 5, 2011
CompletedFirst Posted
Study publicly available on registry
August 11, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedApril 2, 2013
March 1, 2013
1.2 years
August 5, 2011
March 31, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
glucagon/insulin(c-peptide) absolute, incremental and area under curve values
approx. 15 minutes intervals, time 0 to 120 min
Secondary Outcomes (1)
plasma gut hormones and nutrients
approx. 15 minutes intervals, time 0 to 120 min
Study Arms (3)
hyperglycemia
EXPERIMENTALfasting glycemia
EXPERIMENTALhypoglycemia
EXPERIMENTALInterventions
infusion 4 pmol x kg x min first 15 min, thereafter 2 pmol x kg x min
Eligibility Criteria
You may qualify if:
- Caucasians 18 years or older with Type 2 diabetes (WHO criteria)
You may not qualify if:
- HbA1c \>9 %
- Liver disease (ALAT/ASAT \>2 x upper normal limit)
- Diabetic nephropathy (s-creatinine \>130 µM or albuminuria)
- Proliferative diabetic retinopathy (anamnestic)
- Severe arteriosclerosis or heart failure (NYHA group III og IV)
- Anemia
- treatment with medication not applicable to pause for 12 hours
- Fasting plasma glucose \>15 mM on screening day.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gentofte Hospital
Hellerup, 2900, Denmark
Related Publications (2)
Veedfald S, Vedtofte L, Skov-Jeppesen K, Deacon CF, Hartmann B, Vilsboll T, Knop FK, Christensen MB, Holst JJ. Glucose-Dependent Insulinotropic Polypeptide Is a Pancreatic Polypeptide Secretagogue in Humans. J Clin Endocrinol Metab. 2020 Mar 1;105(3):dgz097. doi: 10.1210/clinem/dgz097.
PMID: 31665480DERIVEDChristensen MB, Calanna S, Holst JJ, Vilsboll T, Knop FK. Glucose-dependent insulinotropic polypeptide: blood glucose stabilizing effects in patients with type 2 diabetes. J Clin Endocrinol Metab. 2014 Mar;99(3):E418-26. doi: 10.1210/jc.2013-3644. Epub 2013 Dec 11.
PMID: 24423311DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
August 5, 2011
First Posted
August 11, 2011
Study Start
May 1, 2011
Primary Completion
July 1, 2012
Study Completion
November 1, 2012
Last Updated
April 2, 2013
Record last verified: 2013-03