Association of Kisspeptin Levels With Insulin Secretion in Diabetes Mellitus

NCT01956851 | Completed

• 1 other identifier: CARE/REF/IR/KPT/03/13
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

Since the discovery of kisspeptin as a "gate-keeper" of hypothalamo-pituitary-gonadal axis, there has been tremendous interest in the molecule. The relevance of kisspeptin as regulatory molecule for the reproductive system has been well documented in significant number of trials. (1, 2) This leads to the possibility that kisspeptin could be involved in an equally pivotal role in the other sites, where it is located, namely pancreas. While various animal experiments have suggested that kisspeptins regulate insulin secretion, we do not know if this is also true in humans. The investigators hypothesize that kisspeptin levels are significantly low in individuals who have low endogenous insulin secretion. While various animal experiments have suggested that kisspeptins regulate insulin secretion, the investigators do not know if this is also true in humans. Investigators hypothesize that kisspeptin levels are significantly low in individuals who have low endogenous insulin secretion. Thus investigators are conducting this study to understand the link between endogenous insulin secretion and kisspeptin levels among individuals with various levels of insulin secretory defect as seen in diabetics. Investigators believe that this will help understand the physiologic mechanisms, and kisspeptin based insulin regulation among individuals with diabetes mellitus.

Conditions

Diabetes Mellitus

Keywords

insulin, kisspeptin, GLP 1

Outcome Measures

Primary Outcomes (1)

• correlation of kisspeptin levels with GLP 1

  2 hours post meal

Study Arms (3)

Normal Healthy

Normal Healthy: includes healthy patients eligible for enrolment,

Diabetics on Oral Hypoglycemic Agents

Diabetics on Oral Hypoglycemic Agents: includes diabetic patients on oral diabetic drug therapy with all eligibility criterion fulfilled,

Diabetics on Insulin Therapy

Diabetics on Insulin Therapy: includes diabetic patients on insulin therapy with all eligibility criterion fulfilled

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All patients entering medical and diabetes out patient clinics

You may not qualify if:

• Patients of age group more than 45 yrs and below 25 years
• Pregnant or lactating or post menopausal females.
• Females with irregular menstrual cycles or galactorrhea
• Patients on medications interfering with hormonal functions
• Patients with history suggestive of gonadal dysfunction (hypogonadism primary or secondary)
• Patients with polycystic ovarian disease (PCOD)
• Patients with chronic kidney disease with GFR (Glomerular Filtration rate) \<60ml/min
• Patients receiving gonadal therapy in the form of GnRH (gonadotropin-releasing hormone) agonist or antagonist, estrogen, progesterone or testosterone preparations
• Patients not willing to give informed consent

Sponsors & Collaborators

• Ganga Care Hospital, Nagpur: lead

Study Sites (1)

Ganga Care Hospital

Nagpur, Maharashtra, 440010, India

Location

MeSH Terms

Conditions

Diabetes Mellitus; Insulin Resistance

Condition Hierarchy (Ancestors)

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

Study Officials

• Mamta N Joshi

  Ganga CARE Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: CONSULTANT PHYSICIAN

Study Record Dates

• First Submitted: September 30, 2013
• First Posted: October 8, 2013
• Study Start: September 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: October 27, 2015

Record last verified: 2015-10

Locations

IN (1)