"Hepatic Substrate Flux Rates in Type 2 Diabetes"

NCT04088851 | Active Not Recruiting

• 1 other identifier: IMPACT
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

Investigation of the effects of redox shuttle inhibition by metformin on gluconeogenic flux rates of lactate and glycerol in humans with type 2 diabetes

Conditions

Type 2 Diabetes

Keywords

type 2 diabetes, redox shuttle, gluconeogenesis

Outcome Measures

Primary Outcomes (2)

• Hepatic gluconeogenic flux (U-13C-lactate tracer) (mg/min)

  Hepatic gluconeogenic flux rates from lactate \[mg/min\] in humans with T2D w/wo metformin treatment will be measured by specific tracer metabolism and turnover of the substrates.

  2 weeks

• Hepatic gluconeogenic flux (glycerol tracer) (mg/min)

  Hepatic gluconeogenic flux rates from glycerol \[mg/min\] in humans with T2D w/wo metformin treatment will be measured by specific tracer metabolism and turnover of the substrates.

  2 weeks

Secondary Outcomes (4)

• Endogenous glucose production (mg/min/kg BW)

  2 weeks

• Hepatic mitochondrial oxidative flux (mg/min)

  2 weeks

• Hepatic gammaATP (mmol/L)

  2 weeks

• Hepatic lipid content (%)

  2 weeks

Study Arms (2)

Metformin - T2D

EXPERIMENTAL

Participants with type-2 diabetes will intake metformin 1 g daily for 2 weeks

Drug: On Metformin

No Metformin - T2D

PLACEBO COMPARATOR

Participants with type-2 diabetes will pause metformin 1 g daily for 2 weeks

Drug: Off Metformin

Interventions

On Metformin DRUG

Oral intake of Metformin (1 g / day) for 2 weeks

Metformin - T2D

Off Metformin DRUG

No oral intake of Metformin (1 g / day) for 2 weeks

No Metformin - T2D

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• type 2 diabetes (duration \<7 years),
• age (18-75 years)
• BMI \<40 kg/m2
• HbA1c 6-15%

You may not qualify if:

• uncontrolled hyperglycaemia (\>340 mg/dl)
• diabetes types other than type 2 diabetes (ADA criteria)
• thiazolidinedione use during the preceding 6 months
• clinically relevant angiopathy, restrictive or obstructive lung diseases
• other acute or chronic diseases including wounds and the use of pharmacological agents known to affect insulin sensitivity, lipid metabolism or immunological function.

Sponsors & Collaborators

• German Diabetes Center: lead
• Yale University: collaborator

Study Sites (1)

German Diabetes Center

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Officials

• Michael Roden, Prof., MD

  German Diabetes Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2019
• First Posted: September 13, 2019
• Study Start: September 11, 2019
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 13, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)