The Effect of Vasopressin on Glucose Regulation

NCT02761434 | Completed

• 1 other identifier: 14-12-360
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Data from experimental animals and human epidemiological studies have suggested that hypohydration and/or low water intake is linked to poor glucose regulation and diabetes. The aim of this study is to investigate the effects of cellular dehydration on glucose in healthy non-diabetic individuals. METHODS: 60 males and females (30-55 y) will will undergo two experimental trials (ISO and HYP), consisting of a 2-h intravenous infusion of isotonic or hypertonic saline on two separate occasions, followed by a 4-h oral glucose tolerance test. Blood samples were taken from an antecubital vein in 30-min intervals starting at baseline for assessment of fluid and glucose regulating factors. Thirst will be assessed via visual analog following each blood sample. Energy substrate oxidation will be calculated via indirect calorimetry every 60 min.

Conditions

Insulin Resistance

Keywords

copeptin; vasopressin; dehydration; insulin resistance; Diabetes; Glucose regulation

Outcome Measures

Primary Outcomes (3)

• Glucose area under the curve during the 4 h following ingestion of 75 g glucose

  the area under the glucose curve (AUC) in mg/dL x min

  Within 4 hours of the hypertonic saline infusion

• Insulin area under the curve during the 4 h post ingestion following ingestion of 75 g glucose

  the area under the insulin curve (AUC) in microU/mL x min

  Within 4 hours of the hypertonic saline infusion

• Insulin sensitivity by matsuda & quicki Index

  Within 4 hours of the hypertonic saline infusion

Secondary Outcomes (3)

• Thirst, mouth dryness

  during the experiment every 30 min for the 6 ½ hours of the experiment

• Resting metabolic rate

  every 60 min of the experiment for the 6 ½ hours of the experiment

• Energy substrate oxidation

  every 60 min of the experiment for the 6 ½ hours of the experiment

Study Arms (2)

Dehydration

ACTIVE COMPARATOR

Infusion of 3% sodium chloride for osmotic stimulation of vasopressin

Other: Hypertonic Saline (3% NaCl)

Euhydration

PLACEBO COMPARATOR

Infusion of 0.9% sodium chloride that will induce similar expansion of plasma volume without any significant change in osmolality and vasopressin

Other: Isotonic Saline (0.9% NaCl)

Interventions

Hypertonic Saline (3% NaCl) OTHER

0.1 ml of 3% NaCl per kg of body weight per minute

Dehydration

Isotonic Saline (0.9% NaCl) OTHER

0.1 ml of 0.9% NaCl per kg of body weight per minute

Euhydration

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males or females of age 30-50 y old
• Signed Informed Consent prior to the initiation of any trial procedure
• Sedentary lifestyle

You may not qualify if:

• Body Mass Index (BMI) greater than 35 kg/m2, below 18.5 kg/m2, and between 25 and 28 kg/m2
• Surgical operation on digestive tract, except possible appendectomy
• Regular smoker within the past 6 months
• Diagnosed diabetes (Type I or Type II)
• Previous diagnosis of cardiovascular disease including hypertension
• Inability to participate in the entire study
• Drastic change in weight in the last month (more than 3 kg)
• Serotonin re-uptake inhibitors (i.e. Prozac)
• Impaired kidney or liver function
• Insulin therapy
• injectable contraceptives
• Currently taking medications that impair water balance
• Commuting by bike the day of the experiment
• Pregnancy

Sponsors & Collaborators

• University of Arkansas, Fayetteville: lead
• Danone Global Research & Innovation Center: collaborator

Study Sites (1)

University of Arkansas

Fayetteville, Arkansas, 72701, United States

Location

Related Publications (1)

• Jansen LT, Suh H, Adams JD, Sprong CA, Seal AD, Scott DM, Butts CL, Melander O, Kirkland TW, Vanhaecke T, Dolci A, Lemetais G, Perrier ET, Kavouras SA. Osmotic stimulation of vasopressin acutely impairs glucose regulation: a counterbalanced, crossover trial. Am J Clin Nutr. 2019 Dec 1;110(6):1344-1352. doi: 10.1093/ajcn/nqz236.

  PMID: 31562496 DERIVED

MeSH Terms

Conditions

Insulin Resistance; Diabetes Insipidus; Dehydration; Diabetes Mellitus

Interventions

Saline Solution, Hypertonic; Sodium Chloride

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases; Water-Electrolyte Imbalance; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hypertonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 26, 2016
• First Posted: May 4, 2016
• Study Start: April 13, 2016
• Primary Completion: May 15, 2017
• Study Completion: May 15, 2017
• Last Updated: May 31, 2017

Record last verified: 2017-05

Locations

US (1)