NCT03195257

Brief Summary

Investigate GIP effects on biomarkers involved in bone homeostasis

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2012

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 17, 2012

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 22, 2017

Completed
Last Updated

June 23, 2017

Status Verified

June 1, 2017

Enrollment Period

4 years

First QC Date

June 19, 2017

Last Update Submit

June 21, 2017

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • C-terminal telopeptide of type I collagen (CTX).

    30 minutes intervals, time 0 up to 120 min

Secondary Outcomes (2)

  • Parathyroid hormone (PTH)

    30 minutes intervals, time 0 up to 120 min

  • N-terminal propeptide of type 1 procollagen (P1NP).

    30 minutes intervals, time 0 up to 120 min

Study Arms (5)

Hypoglycemia-saline

PLACEBO COMPARATOR
Other: Saline

Hypoglycemia-GIP

EXPERIMENTAL
Other: GIP

Hypoglycemia-GLP-1

ACTIVE COMPARATOR
Other: GLP-1

Hyperglycemia-GIP

EXPERIMENTAL
Other: GIP

Hyperglycemia-Saline

PLACEBO COMPARATOR
Other: Saline

Interventions

GIPOTHER

On 3 matched days with 'hypoglycemia' (i.e. plasma glucose clamped between 3-7 mol/L for 120 minutes) either GIP (4 pmol/kg/min), glucagon-like-peptide-1 (GLP-1) (1 pmol/kg/min) or placebo (saline) was administered; and on 2 separately matched days with 'hyperglycemia' (i.e. clamped at 12 mmol/L for 90 minutes) either GIP (4 pmol/kg/min) or saline was administered.

Also known as: Glucose-Dependent Insulinotropic Polypeptide
Hyperglycemia-GIPHypoglycemia-GIP
GLP-1OTHER

On 3 matched days with 'hypoglycemia' (i.e. plasma glucose clamped between 3-7 mol/L for 120 minutes) either GIP (4 pmol/kg/min), glucagon-like-peptide-1 (GLP-1) (1 pmol/kg/min) or placebo (saline) was administered; and on 2 separately matched days with 'hyperglycemia' (i.e. clamped at 12 mmol/L for 90 minutes) either GIP (4 pmol/kg/min) or saline was administered.

Also known as: glucagon-like-peptide-1
Hypoglycemia-GLP-1
SalineOTHER

On 3 matched days with 'hypoglycemia' (i.e. plasma glucose clamped between 3-7 mol/L for 120 minutes) either GIP (4 pmol/kg/min), glucagon-like-peptide-1 (GLP-1) (1 pmol/kg/min) or placebo (saline) was administered; and on 2 separately matched days with 'hyperglycemia' (i.e. clamped at 12 mmol/L for 90 minutes) either GIP (4 pmol/kg/min) or saline was administered.

Also known as: placebo
Hyperglycemia-SalineHypoglycemia-saline

Eligibility Criteria

Age18 Years - 50 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with type 1 diabetes (positive islet cell/ glutamic acid decarboxylase-65 antibodies)
  • Patients without measurable beta cell function (i.e. incremental C-peptide below detection limit (\<0.16 nmol/l) following an 5 g-iv-arginine stimulation test,

You may not qualify if:

  • HbA1c \>9% (75 mmol/mol),
  • standard plasma biochemical measurements outside normal reference interval (alanine aminotransferase, bilirubin, thyroid-stimulating hormone, hemoglobin, creatinine, and spot urine albumin-creatinine ratio);
  • an abnormal state of hypoglycemia awareness,
  • significant diabetic complications (i.e. proliferative diabetic retinopathy, neuropathy, severe atherosclerosis, heart disease) and,
  • treatment with medication (besides insulin) that could not be paused for 12 hours up to and during the days of the experiments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Christensen MB, Lund A, Calanna S, Jorgensen NR, Holst JJ, Vilsboll T, Knop FK. Glucose-Dependent Insulinotropic Polypeptide (GIP) Inhibits Bone Resorption Independently of Insulin and Glycemia. J Clin Endocrinol Metab. 2018 Jan 1;103(1):288-294. doi: 10.1210/jc.2017-01949.

    PMID: 29099978DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

IncretinsGlucagon-Like Peptide 1Sodium Chloride

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

HormonesHormones, Hormone Substitutes, and Hormone AntagonistsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesGlucagon-Like PeptidesProglucagonGastrointestinal HormonesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Randomized, double-blinded, cross-over study with 5 study days.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor, Principal Investigator

Study Record Dates

First Submitted

June 19, 2017

First Posted

June 22, 2017

Study Start

November 17, 2012

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

June 23, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share