GIP: Glucose-dependent Insulinotropic Peptide

NCT00239707 | Completed Phase 1

• 1 other identifier: AG0056
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test the safety of glucose-dependent insulinotropic peptide (GIP)/GIP Analog on people with Type 2 Diabetes.

Conditions

Type 2 Diabetes

Keywords

insulin sensitivity; blood sugar

Outcome Measures

Primary Outcomes (1)

• GIP, glucose, insulin measured frequently during infusions

  baseline, 2 months, and 4 months

Secondary Outcomes (1)

• GLP-1, ghrelin measured frequently during infusions

  baseline, 2 months, and 4 months

Study Arms (3)

Infusion 1

EXPERIMENTAL

Normal Saline

Drug: GIP

Infusion 2

PLACEBO COMPARATOR

GIP or modified GIP

Drug: Modified GIP

Infusion 3

PLACEBO COMPARATOR

GIP or modified GIP, opposite of Infusion 2

Drug: Normal Saline

Interventions

GIP DRUG

One-time 20 ng/kg/min infusion over 3 hours

Also known as: Glucose dependent insulinotropic peptide

Infusion 1

Modified GIP DRUG

One-time infusion over 3 hours; dose to maintain desired biological effect of below 140 mg/dl

Also known as: GIP analog

Infusion 2

Normal Saline DRUG

one-time infusion over 3 hours

Also known as: Saline

Infusion 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age and older
• Healthy Type 2 Diabetics
• Agree to stay off glucosidases for 3 days prior to infusion visits (Examples: Precose, Glyset)
• Agree to stay off Sulfonylureas 5 days prior to infusion visits (Examples: Glucotrol, Amaryl, glyburide, metformin
• Able to ingest 1000 mg Tylenol on study visits
• Able to consume study breakfast consisting of scrambled egg, white toast with margarine, corn flakes, 2% milk, banana at each infusion visit
• Female participants must have Hct \> 36
• Male participant must have Hct \> 38
• No kidney or liver disease per history and evidenced by blood and urine tests
• Physical Exam and EKG that do not contraindicate patient to be in the study

You may not qualify if:

• Taking the following medications: Insulin, or Thiazolidinediones, i.e. Avandia, Actos
• Pregnancy
• Steroid use within the past 3 months
• Recent infection, fever or chills

Sponsors & Collaborators

• National Institute on Aging (NIA): lead

Study Sites (1)

National Institute on Aging, Clinical Research Branch

Baltimore, Maryland, 21225, United States

Location

Related Publications (4)

• Elahi D, Andersen DK, Brown JC, Debas HT, Hershcopf RJ, Raizes GS, Tobin JD, Andres R. Pancreatic alpha- and beta-cell responses to GIP infusion in normal man. Am J Physiol. 1979 Aug;237(2):E185-91. doi: 10.1152/ajpendo.1979.237.2.E185. No abstract available.

  PMID: 464094 BACKGROUND

• Nauck MA, Heimesaat MM, Orskov C, Holst JJ, Ebert R, Creutzfeldt W. Preserved incretin activity of glucagon-like peptide 1 [7-36 amide] but not of synthetic human gastric inhibitory polypeptide in patients with type-2 diabetes mellitus. J Clin Invest. 1993 Jan;91(1):301-7. doi: 10.1172/JCI116186.

  PMID: 8423228 BACKGROUND

• Elahi D, McAloon-Dyke M, Fukagawa NK, Meneilly GS, Sclater AL, Minaker KL, Habener JF, Andersen DK. The insulinotropic actions of glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (7-37) in normal and diabetic subjects. Regul Pept. 1994 Apr 14;51(1):63-74. doi: 10.1016/0167-0115(94)90136-8.

  PMID: 8036284 BACKGROUND

• Chia CW, Odetunde JO, Kim W, Carlson OD, Ferrucci L, Egan JM. GIP contributes to islet trihormonal abnormalities in type 2 diabetes. J Clin Endocrinol Metab. 2014 Jul;99(7):2477-85. doi: 10.1210/jc.2013-3994. Epub 2014 Apr 8.

  PMID: 24712564 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Interventions

Gastric Inhibitory Polypeptide; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Josephine Egan, MD

  Chief, Diabetes Section, National Institute on Aging

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2005
• First Posted: October 17, 2005
• Study Start: February 1, 2003
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: November 28, 2013

Record last verified: 2013-11

Locations

US (1)