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GIP Effects at Insulin Induced Hypoglycemia in Patients With Type 2 Diabetes (GIP-HYPO-T2DM)

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Early Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Glucose-dependent Insulinotropic polypeptide
saline
Sponsored by
Mikkel Christensen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Caucasians 18 years or older with Type 2 diabetes (WHO criteria)

Exclusion Criteria:

  • 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.

Sites / Locations

  • Gentofte Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

hyperglycemia

fasting glycemia

hypoglycemia

Arm Description

Outcomes

Primary Outcome Measures

glucagon/insulin(c-peptide) absolute, incremental and area under curve values

Secondary Outcome Measures

plasma gut hormones and nutrients

Full Information

First Posted
August 5, 2011
Last Updated
March 31, 2013
Sponsor
Mikkel Christensen
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1. Study Identification

Unique Protocol Identification Number
NCT01414556
Brief Title
GIP Effects at Insulin Induced Hypoglycemia in Patients With Type 2 Diabetes
Acronym
GIP-HYPO-T2DM
Official Title
Effects of Glucose-dependent Insulinotropic Polypeptide at Insulin Induced Hypoglycemia in Patients With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mikkel Christensen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Investigation of GIP effects at fasting and hypoglycemia

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
hyperglycemia
Arm Type
Experimental
Arm Title
fasting glycemia
Arm Type
Experimental
Arm Title
hypoglycemia
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Glucose-dependent Insulinotropic polypeptide
Intervention Description
infusion 4 pmol x kg x min first 15 min, thereafter 2 pmol x kg x min
Intervention Type
Other
Intervention Name(s)
saline
Primary Outcome Measure Information:
Title
glucagon/insulin(c-peptide) absolute, incremental and area under curve values
Time Frame
approx. 15 minutes intervals, time 0 to 120 min
Secondary Outcome Measure Information:
Title
plasma gut hormones and nutrients
Time Frame
approx. 15 minutes intervals, time 0 to 120 min

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Caucasians 18 years or older with Type 2 diabetes (WHO criteria) Exclusion Criteria: 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.
Facility Information:
Facility Name
Gentofte Hospital
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
31665480
Citation
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.
Results Reference
derived
PubMed Identifier
24423311
Citation
Christensen 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.
Results Reference
derived

Learn more about this trial

GIP Effects at Insulin Induced Hypoglycemia in Patients With Type 2 Diabetes

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